Drug Register (November 2024)
This list is updated regularly when available data on such products are evaluated and relevant sites are inspected by National Drug Authority. Please enter the criteria below to display products from the Drug Register database.

Herbal Human

S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURING SITECOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
1NDA/MAL/HHP/10019CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDLIVOMYN TABLETSCHARAK PHARMA PRIVATE LIMITED, JAURASI ROAD, PAUTI VILLAGE, SAMALKHA, DIST. PANIPAT - 132 101, HARYANA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X20.0 TABLET BLISTER07/03/2022
2NDA/MAL/HHP/10027BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDACTIVATED CHARCOAL TABLETSBHARGAVA PHYTOLAB PVT.LTD, E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X90.0 TABLET BOTTLE21/04/2022
3NDA/MAL/HHP/10406GAYATRI AYUPHARMA PRIVATE LIMITEDVIDA AFRICA LTDLOTUS FEMIWASHGAYATRI AYUPHARMA PRIVATE LIMITED, 234/2/2, PATEL ESTATE, NIKOL ROAD, AHMEDABAD: 382 350, GUJARAT (INDIA)INDIATOPICAL EXTERNAL LIQUIDS 1.0X25.0 ML BOTTLE04/10/2022
4NDA/MAL/HHP/10411BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDFRICKS ORANGE LOZENGESLOZEN PHARMA PRIVATE LIMITED, RAGHAV ESTATE, KSSIDC, INDUSTRIAL AREA, SAVANUR, DISTT. HAVERI, KARNATAKA - 581 118, INDIAINDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE BLISTER16/11/2022
5NDA/MAL/HHP/10412BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDFRICKS MENTHOL LOZENGESLOZEN PHARMA PRIVATE LIMITED, RAGHAV ESTATE, KSSIDC, INDUSTRIAL AREA, SAVANUR, DISTT. HAVERI, KARNATAKA - 581 118, INDIAINDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE BLISTER16/11/2022
6NDA/MAL/HHP/10413BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDFRICKS HONEY LEMON LOZENGESLOZEN PHARMA PRIVATE LIMITED, RAGHAV ESTATE, KSSIDC, INDUSTRIAL AREA, SAVANUR, DISTT. HAVERI, KARNATAKA - 581 118, INDIAINDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE BLISTER16/11/2022
7NDA/MAL/HHP/10500GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDASCORIL NATURA SYRUPTHE MADRAS PHARMACEUTICALS.., NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE02/12/2022
8NDA/MAL/HHP/11328ADMARK HERBALS LIMITEDAAFIYA (A) LIMITEDIMMUNE UPLIFT HERBAL CAPSULESADMARK HERBAL LIMITED, JETPUR ROAD, N.H. NO. 8-B, DHORAJ 360410, GUJARATINDIAORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE TIN07/05/2024
9NDA/MAL/HHP/11501ZYDUS LIFESCIENCES LTD.ABACUS PHARMA (AFRICA) LIMITEDSIMBA PAIN BALMEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X10.0 ML CONTAINER03/07/2024
10NDA/MAL/HHP/11502 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDREVITALSOFTESULE PRIVATE LIMITED, PLOT O. 86-A, L.B.S MARG, MULUND (W) MUMBAI 400080 - INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X30.0 CAPSULE BOTTLE20/08/2024
11NDA/MAL/HHP/3115CINCINNATI CHILDREN€™S HOSPITAL SHURIK LTDRHINO BALMMEHTA UNANI PHARMACY & CO LTD, INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER01/07/2001
12NDA/MAL/HHP/5500CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDAPTIZOOOM SYRUPCHARAK PHARMA PRIVATE LIMITED, JAURASI ROAD, PAUTI VILLAGE, SAMALKHA, DIST. PANIPAT - 132 101, HARYANA, INDIA| CHARAK PHARMA PVT. LTD,, PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2000
13NDA/MAL/HHP/5518MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDPENODEX OINTMENTMEHTA UNANI PHARMACY & CO LTD, INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G CONTAINER01/07/2007
14NDA/MAL/HHP/5519AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDAPDYL-H, HERBAL COUGH SYRUPAJANTA PHARMA LTD - , 31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABAD| SAVERA PHARMACEUTICALS PVT LTD -, H-39 & 40, M.I.D.C, WALUJ, AURANGABAD, INDIA.INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2004
15NDA/MAL/HHP/5528VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDAQUAREST288,SIDCO ESTATE, AMBATTUR, CHENNAI 600 098, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY POWDERS 1.0X10.0X765.0 MG SACHET01/07/2009
16NDA/MAL/HHP/5532MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDATMANANTHAN COLD RUBMETA UNANI PHARMACY & CO PVT, G 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATIINDIANASAL TOPICAL LIQUID INHALATIONS 1.0X12.0X1.0 G ROD01/07/2009
17NDA/MAL/HHP/5536ABACUS (A) PHARMA LTDJEET PHARMACEUTICALS LIMITEDMENTHO PLUS PAIN BALMEMAMI LTD, EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIANASAL 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
18NDA/MAL/HHP/5546CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDPAEDRITONE SYRUPCHARAK PHARMA PVT LTD,, EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2015
19NDA/MAL/HHP/5550CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDGUM TONE GELCHARAK PHARMA PVT LTD,, EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAINDIAORAL TOPICAL GELS AND SOLS 1.0X50.0 G TUBE01/07/2015
20NDA/MAL/HHP/5553ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDMENTHOXYL DOUBLE ACTION HERBAL COUGH LOZENGESLEAMARK HEALTHCAREPVT LTD, SARKHEJ-BAVLA HIGHWAY MATODA AHMEDABADINDIAORAL SOLID ORDINARY LOZENGES 1.0X10.0X2.0 LOZENGE STRIP,1.0X50.0X2.0 LOZENGE STRIP01/07/2009
21NDA/MAL/HHP/5559CINCINNATI CHILDREN€™S HOSPITAL SHURIK LTDSTAR SKIN OINTMENTMEHTA UNANI PHARMACY & CO LTD, INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X12.0 G TUBE01/07/2001
22NDA/MAL/HHP/5567ABACUS (A) PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEW EMAMI MENTHOPLUS RELAXING BALMEMAMI LTD, EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIATOPICAL EXTERNAL LIQUIDS 1.0X8.0 ML JAR01/07/2015
23NDA/MAL/HHP/5570PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDSITCOMPANACEA BIOTEC PHARMA LIMITED, MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER01/07/2013
24NDA/MAL/HHP/5571ABACUS (A) PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDRAGON LIQUID BALMAMRUTANJAN HEALTH CARE LIMITED, PLOT NO 37,38&39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TALUK, KANCHEEPURAM DISTRICT 603110, INDIAINDIATOPICAL EXTERNAL OTHER OINTMENTS 1.0X10.0 ML CONTAINER,1.0X5.0 ML CONTAINER01/07/2004
25NDA/MAL/HHP/5572CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDVIGOMAX FORTE CHARAK PHARMA PVT LTD, JAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X20.0 TABLET BLISTER01/07/2011
26NDA/MAL/HHP/5574AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEW PINKOO GRIPE WATERAJANTA PHARMA LIMITED, 31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE01/07/2009
27NDA/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 1.0X60.0 ML BOTTLE01/07/2016
28NDA/MAL/HHP/5587CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDMANOLL SYRUP CHARAK PHARMA PVT LTD, JAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIA| CHARAK PHARMA PVT. LTD,, PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X250.0 MG BOTTLE01/07/2016
29NDA/MAL/HHP/5588CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL (HONEY LEMON FLAVOUR)CHARAK PHARMA PVT LTD,, EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAINDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X6.0 LOZENGE BLISTER01/07/2014
30NDA/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 INDIAINDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP01/07/2005
31NDA/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 INDIAINDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP01/07/2005
32NDA/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.INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE01/07/2000
33NDA/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 INDIAINDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP01/07/2014
34NDA/MAL/HHP/6848CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL (MINT)LEAMARK HEALTHCARE PVT LTD, SARKHEJ BAVLA HIGHWAY,MATODA 382213 AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY LOZENGES 1.0X3.0X4.0 LOZENGE BLISTER,1.0X2.0X6.0 LOZENGE BLISTER01/07/2016
35NDA/MAL/HHP/6853WILSHIRE LABORATORIES (PVT) LTD HEALTHCARE LTD.LIV-LONG TABLETWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN | PAKISTANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2016
36NDA/MAL/HHP/7934STAR PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR RUBEFACIENTGLENMARK PHARMACEUTICAL LIMITED, 61-62 COMPOUND, DEWAS NAKA, LASUDIA MORIINDIATOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE01/07/2015
37NDA/MAL/HHP/7937GLENMARK PHARMACEUTICAL LTD STAR PHARMACEUTICALS LTDSENSUR OILGLENMARK PHARMACEUTICAL LIMITED, 61-62 COMPOUND, DEWAS NAKA, LASUDIA MORIINDIATOPICAL EXTERNAL LIQUIDS 1.0X10.0 ML VIAL01/07/2015
38NDA/MAL/HHP/7940GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR LOTIONSYDLER REMEDIES, PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA| GLENMARK PHARMACEUTICAL LIMITED, 61-62 COMPOUND, DEWAS NAKA, LASUDIA MORIINDIATOPICAL EXTERNAL OTHER CREAMS 1.0X50.0 ML BOTTLE01/07/2015
39NDA/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
THAILANDORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2016
40NDA/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 INDIAINDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP01/07/2014
41NDA/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.INDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE CONTAINER01/07/2016
42NDA/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 INDIAINDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP01/07/2014
43NDA/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 INDIAINDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP01/07/2014
44NDA/MAL/HHP/7955KREMOINT PHARMA PVT.LTDPLANET PHARMACEUTICALS UGANDA LTDDICLODAY ROLL-ONKREMOINT PHARMA PVT LTD, B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA INDIATOPICAL EXTERNAL EMULSIONS 1.0X50.0 ML BOTTLE03/12/2016
45NDA/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 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2015
46NDA/MAL/HHP/7966BHARGAVA PHYTOLAB PVT LTDREDDYS PHARMA LIMITEDKIDFLAMEBHARGAVA PHYTOLAB PVT LTD, B-92, SECTOR €“ 2 , NOIDA €“ 201301, U.P. ( INDIA)INDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X5.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER01/07/2015
47NDA/MAL/HHP/8094BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDPROSTORALBHARGAVA PHYTOLAB PVT. LTD , E-1216, PHASE €“ 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X15.0 TABLET BLISTER01/07/2017
48NDA/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 INDIATOPICAL EXTERNAL LOTIONS 1.0X50.0 ML CONTAINER01/07/2004
49NDA/MAL/HHP/8220AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNOCOLICAJANTA PHARMA LTD - , 31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABADINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE01/07/2017
50NDA/MAL/HHP/8379CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDM2 TONE TABLET CHARAK PHARMA PVT LTD, INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE20/09/2017
51NDA/MAL/HHP/8385GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).TRIDEM PHARMA UGANDA LIMITEDMEBOSCAR OINTMENTGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH | 		UNITED ARAB EMIRATES | TOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE24/10/2017
52NDA/MAL/HHP/8505CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDLIVOMYN SYRUP CHARAK PHARMA PVT LTD, INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011| CHARAK PHARMA PVT. LTD,, PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE02/02/2018
53NDA/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. INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE02/02/2018
54NDA/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 LTD, INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE02/02/2018
55NDA/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. INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X20.0 CAPSULE BLISTER29/11/2017
56NDA/MAL/HHP/8510BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDFRICKS COUGH SYRUPBLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE06/03/2018
57NDA/MAL/HHP/8511BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDTHUNDER-MBHARGAVA PHYTOLAB PVT. LTD , E-1216, PHASE €“ 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2017
58NDA/MAL/HHP/8513BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDMENIPHIBBHARGAVA PHYTOLAB PVT. LTD , E-1216, PHASE €“ 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X20.0 TABLET BLISTER01/07/2016
59NDA/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		INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X10.0 ML TUBE24/11/2017
60NDA/MAL/HHP/8553RAZA INTERNATIONALWIDE SPECTRUM ENTERPRISES (U) LIMITEDHONEY CUREOZONE COSMETICS & NATURAL PRODUCTS MANUFACTURING COMPANYˆŠ, SHARA BADRAN, MARJ ALFARAS, INDUSTRIAL ZONE, MUSAWAA STREET.
OZONE INDUSTRIAL COMPLEX. P.O. BOX : 1764. AMMAN 11953, JORDAN		JORDANTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE,1.0X15.0 G TUBE13/07/2017
61NDA/MAL/HHP/8556MANKIND PHARMA LTD.TATA UGANDA LIMITEDUNIORTHO-500TIRUPATI LIFESCIENCES, NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER10/11/2017
62NDA/MAL/HHP/9093BETA HEALTHCARE INTERNATIONAL LIMITEDBETA HEALTHCARE UGANDA LIMITEDCOFTA EXTRA SYRUPBETA HEALTHCARE INTERNATIONAL LTD , PLOT NO LR 209/6534 MOGADISHU ROADKENYAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE22/03/2019
63NDA/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. INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X20.0 CAPSULE BLISTER29/01/2020
64NDA/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 396210INDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP18/07/2020
65NDA/MAL/HHP/9332MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA IVY SYRUPMEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILANDTHAILANDORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE31/08/2020
66NDA/MAL/HHP/9333MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA MOUTH SPRAYMEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILANDTHAILANDORAL TOPICAL SPRAYS WITHOUT GAS 1.0X10.0 ML BOTTLE31/08/2020
67NDA/MAL/HHP/9703GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDCURODEX OINTMENTRAJESH PHARMACEUTICALS, 7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481INDIATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G BOTTLE27/08/2021
68NDA/MAL/HHP/9704GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDMENTHOXYL INHALERRAJESH PHARMACEUTICALS, 7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481INDIANASAL TOPICAL LIQUID INHALATIONS 1.0X0.5 ML INHALER27/08/2021
69NDA/MAL/HHP/9711MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDGINSOMINMEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILANDTHAILANDORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER07/10/2021

Herbal Vet

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

Human

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
UGANDAOPHTHALMIC DROPS 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL01/07/2011
2NDA/MAL/HDP/0006HOVID BHD UNITED HEALTHCARE DISTRIBUTORS LTDDIAMIDEGLIBENCLAMIDE + METFORMIN HYDROCHLORIDE5MG + 500MGHOVID BERHAD,, LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAKMALAYSIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X12.0 TABLET BLISTER01/07/2014
3NDA/MAL/HDP/0007GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROCIP SYRUPCYPROHEPTADINE HYDROCHLORIDE2MG/5MLAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2013
4NDA/MAL/HDP/0012HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDPENGESIC SR TRAMADOL HYDROCHLORIDE SR 100MGHOVID BHD, LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIAMALAYSIAORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
5NDA/MAL/HDP/0016REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCODIMEX-CT TABLETSCETIRIZINE DIHYDROCHLORIDE10MGREGAL PHARMACEUTICALS LIMITED , PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
6NDA/MAL/HDP/0017SWISS PARENTERALS LTDSHREEJI PHARMACEUTICALS LIMITEDS-HYDROHYDROCORTISONE100MGSWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X7.5 ML VIAL, 1.0X50.0X100.0 MG VIAL03/06/2021
7NDA/MAL/HDP/0022GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2009
8NDA/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
INDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X2.0 ML AMPOULE01/07/2015
9NDA/MAL/HDP/0031MANKIND PHARM LTDTATA UGANDA LIMITEDCEFTATIME-SB 1.5CEFTRIAXONE+SULBACTAM1000MG+500MGMANKIND PHARMA LTD-, VILLAGE KISHANPURA P.O JAMNI WALA TEHSIL PAONTA SAHIB DISTT SIRMOUR 173025 HIMACHAL PRADESHINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.5 G VIAL01/07/2015
10NDA/MAL/HDP/0041 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECIMCIMETIDINE200MGRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
11NDA/MAL/HDP/0045GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL CAPLETSPARACETAMOL500MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2007
12NDA/MAL/HDP/0050MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.VIGORAMASILDENAFIL50MGMEDICAL UNION PHARMACEUTICALS LTD, ABU SULTAN, ISMAILLIA, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET STRIP01/07/2013
13NDA/MAL/HDP/0052MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM0.5%W/VMEDICAL UNION PHARMACEUTICAL CO., PLANT: ABU-SULTAN, ISMAILIA, EGYPTEGYPTTOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE,1.0X30.0 G TUBE01/07/2014
14NDA/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 506INDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2013
15NDA/MAL/HDP/0056TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR QPS DICLOFENAC4%W/VTROIKAA PHARMACEUTICALS LTD, THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA| TROIKAA PHARMACEUTICALS LTD, BLOCK NO. 2019, 2020, 2023, VILLAGE VIROCHANNAGAR, TAL-SANAND CITY: AHMEDABAD, DIST. AHMEDABAD-382170, GUJARAT STATEINDIATOPICAL EXTERNAL SPRAYS WITHOUT GAS 1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE01/07/2015
16NDA/MAL/HDP/0058ACULIFE HEALTHCARE PVT LTDSUPER MEDIC LTDWATER FOR INJECTION B.P.WATER FOR INJECTIONN/AACULIFE HEALTHCARE PVT. LTD, VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE01/07/1997
17NDA/MAL/HDP/0059NABIQASIM INDUSTRIES (PVT) LTD. JEET PHARMACEUTICALS LIMITEDVAGIBACT CREAMCLINDAMYCIN PHOSPHATE2%W/WNABIQASIM INDUSTRIES (PVT) LTDˆŠ, 17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.
PAKISTANTOPICAL EXTERNAL CREAMS 1.0X40.0 G TUBE + 1 APPLICATOR01/07/2006
18NDA/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 S.A , SUCCURSALE D'AUBONNE, ZONE INDUSTRIELLE DE L'OURIETTAZ, 1170 AUBONNE, SWITZERLAND| MERCK SERONO SPA (BARI), VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARIITALY| SWITZERLANDPARENTERAL ORDINARY PRE-FILLED PENS 1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION01/07/2015
19NDA/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.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER01/07/2015
20NDA/MAL/HDP/0064MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 450 IU/ IE 0,75 ML (33 µG)FOLLITROPIN ALFA33µG/ 0.7MLMERCK SERONO S.A. (MSA) , 1170 SUCCURSALE D€™AUBONNE ZONE INDUSTRIELLE DE L€™OURIETTAZ, SWITZERLAND| MERCK SERONO SPA (BARI), VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARISWITZERLANDPARENTERAL ORDINARY CARTRIDGES 1.0X1.0 CARTRIDGE PREFILLED PEN + 12 NEEDLES FOR INJECTION01/07/2015
21NDA/MAL/HDP/0065HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDALENDRONATE 70MGALENDRONATE SODIUM70MGHOVID BHD, LOT 56442 7 1/2 MILES JALAN IPOH / CHEMOR 31200 CHEMORMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER01/07/2015
22NDA/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, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER01/07/2014
23NDA/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
UGANDAOPHTHALMIC DROPS 1.0X10.0 ML VIAL01/07/2015
24NDA/MAL/HDP/0079MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDREVOKE 72LEVONORGESTREL750MCGMYLAN LABORATORIES LIMITED.-, PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.| MYLAN LABORATORIES LIMITED.., PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET BLISTER01/07/2014
25NDA/MAL/HDP/0083MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDZINNIA-FLEVONORGESTREL & ETHINYLESTRADIOL + FERROUS FUMARATE150MCG + 30MCG + 75MGMYLAN LABORATORIES LIMITED.-, PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.| MYLAN LABORATORIES LIMITED.., PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X28.0 TABLET BLISTER01/07/2014
26NDA/MAL/HDP/0088GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDD-LYTE CO-PACKANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC2.7MG+0.52MG+0.58MG+0.30MG+20MG PER 200ML,6.75MG+1.30MG+1.45MG+0.75MG+20MG PER 500ML SACHET,13.5MG+2.60MG+2.90MG+1.50MG+20MG PER 1000ML SACHETAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL 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
27NDA/MAL/HDP/0097MSN LABORATORIES PRIVATE LIMITED,METRO PHARMACEUTICALS LIMITEDSAFELEVO 750LEVOFLOXACIN 750MGMSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2013
28NDA/MAL/HDP/0098MSN LABORATORIES PRIVATE LIMITED,STAR PHARMACEUTICALS LTDATOREM 10ATORVASTATIN10MGMSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
29NDA/MAL/HDP/0101GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTETRA CAPSULES TETRACYCLINE HYDROCHLORIDE250MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL 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
30NDA/MAL/HDP/0102MSN LABORATORIES PRIVATE LIMITED,METRO PHARMACEUTICALS LIMITEDSILMELT 100SILDENAFIL CITRATE100MGMSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X2.0 TABLET BLISTER01/07/2014
31NDA/MAL/HDP/0103MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDATOREM 20ATORVASTATIN20MGMSN LABORATORIES LTD, PLOT N0.42, ANRICH INDUSTRIAL ESTATEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
32NDA/MAL/HDP/0104MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSILMELT 50SILDENAFIL CITRATE50MGMSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X2.0 TABLET BLISTER01/07/2014
33NDA/MAL/HDP/0105GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSPRIN TABLETSACETYL SALICYLIC ACID300MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL 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
34NDA/MAL/HDP/0110MSN LABORATORIES PRIVATE LIMITEDSTAR PHARMACEUTICALS LTDSAFETELMI 40TELMISARTAN40MGMSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
35NDA/MAL/HDP/0111MSN LABORATORIES PRIVATE LIMITEDSTAR PHARMACEUTICALS LTDSAFETELMI 80TELMISARTAN80MGMSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
36NDA/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 BLISTER01/07/2004
37NDA/MAL/HDP/0114MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDBREATHEZY 4MONTELUKAST SODIUM 4MGMSN LABORATORIES LTD , PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
38NDA/MAL/HDP/0116MSN LABORATORIES PRIVATE LIMITEDSTAR PHARMACEUTICALS LTDBREATHEZY CW 5MONTELUKAST SODIUM5MGMSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
39NDA/MAL/HDP/0119DAWA LIMITEDSUPER MEDIC LTDDACOLDCAFFEINE ANHYDROUS+CHLORPHENIRAMINE MALEATE+PARACETAMOL+PSEUDOEPHEDRINE30MG+4MG+400MG+30MGDAWA LIMITED , BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
40NDA/MAL/HDP/0124DAWA LIMITEDSUPER MEDIC LTDAMPECINAMPICILLIN TRIHYDRATE125MG/5MLDAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2015
41NDA/MAL/HDP/0125DAWA LIMITED SUPER MEDIC LTDSULPHUR OINTMENTSULPHUR10%W/WDAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G TUBE01/07/2013
42NDA/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 | KENYAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE24/02/2021
43NDA/MAL/HDP/0139DAWA LIMITED-SUPER MEDIC LTDMOXAFORTEFLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE250MG + 250MGDAWA PHARMACEUTICALS LIMITED, PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER01/07/2014
44NDA/MAL/HDP/0157RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECODINCODEINE PHOSPHATE + CHLORPHENIRAMINE MALEATE10MG + 4MG /5MLRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2015
45NDA/MAL/HDP/0160UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDTIZIGESICTIZANIDINE HYDROCHLORIDE2MGUNICHEM LABORATORIES LIMITED, C€“31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2016
46NDA/MAL/HDP/0161RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTRAMARENTRAMADOL HYDROCHLORIDE50MGRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2014
47NDA/MAL/HDP/0162 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOSYP-D LINCTUSDEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE10MG +4MG /5MLRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2015
48NDA/MAL/HDP/0163RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPHENAREN PROMETHAZINE HYDROCHLORIDE5MG/5MLRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE01/07/2015
49NDA/MAL/HDP/0164RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENPRESSPROPRANOLOL40MGRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
50NDA/MAL/HDP/0165TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 5OLANZAPINE ORODISPERSIBLE TABLETS5MGTORRENT PHARMACEUTICALS LTD .,, AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARATINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
51NDA/MAL/HDP/0166RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MG/5MLRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE01/07/2015
52NDA/MAL/HDP/0167TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 10OLANZAPINE ORODISPERSIBLE TABLETS10MGTORRENT PHARMACEUTICALS LTD .,, AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARATINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
53NDA/MAL/HDP/0168MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFEBUDAYFEBUXOSTAT80MGMSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
54NDA/MAL/HDP/0175BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDXARELTO 10MGRIVAROXABAN10MGBAYER HEALTHCARE AG,, D-51368, LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/07/2009
55NDA/MAL/HDP/0177MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDILET B2 GLIMEPIRIDE2MGMSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
56NDA/MAL/HDP/0178REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCOLDCAP DAYTIME AND NIGHT TIME CAPSULE DAY TIME(PARACETAMOL +CAFFEINE ANHYDROUS+PSEUDOEPHEDRINE HCL) AND NIGHT TIME(PARACETAMOL +CHLORPHENIRAMINE MALEATE)DAY TIME (500MG + 30MG + 30MG) AND NIGHT TIME (500MG +2MG)REGAL PHARMACEUTICALS LIMITED , PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYAORAL SOLID ORDINARY CAPSULES 1.0X3.0X8.0 CAPSULE BLISTER01/07/2013
57NDA/MAL/HDP/0182MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFEBUDAY 40FEBUXOSTAT 40MGMSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
58NDA/MAL/HDP/0186WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDBBC SPRAYBENZOCAINE+BENZYDAMINE+CATALKONIUM CHLORIDE1.5%W/V+0.15%W/V+0.0413%W/VAMOUN PHARMACEUTICALS CO. S.A.E, 1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTORAL TOPICAL SPRAYS WITHOUT GAS 1.0X25.0 ML BOTTLE01/07/2014
59NDA/MAL/HDP/0187AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDKAPRON TABLET TRANEXAMIC ACID500 MGAMOUN PHARMACEUTICALS CO. S.A.E, 1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER01/07/2014
60NDA/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 NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE01/07/2013
61NDA/MAL/HDP/0193MEDOPHARM, INDIAVITACARE LIMITEDCLEDOMOX 625AMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGMEDOPHARM PVT LTD., NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER,1.0X2.0X10.0 TABLET STRIP01/07/2013
62NDA/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, KAMPALAUGANDAORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X60.0 TABLET CONTAINER01/07/2013
63NDA/MAL/HDP/0203GLAXOSMITHKLINE TRADING SERVICES LTD, UNITED HEALTHCARE DISTRIBUTORS LTDSERETIDE EVOHALER 250SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 250MCGGLAXO WELLCOME, PRODUCTION ZONE INDUSTRIELLE NO. 2 23, RUE LAVOISIER 27000 EVREUXFRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER01/07/2015
64NDA/MAL/HDP/0204VIIV HEALTHCARE UK LTD-UNITED HEALTHCARE DISTRIBUTORS LTDTIVICAYDOLUTEGRAVIR SODIUM50MGGLAXO OPERATIONS UK LTD, WARE SG120DJ UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2015
65NDA/MAL/HDP/0209HETERO LABS LTD AIVEEN (U) LIMITEDABACAVIR SULPHATE ORAL SOLUTIONABACAVIR SULPHATE20MG/MLHETERO LABS PRIVATE LIMITED UNIT III, SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATEINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X240.0 ML BOTTLE01/07/2013
66NDA/MAL/HDP/0210MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN140MGMEDICAL UNION PHARMACEUTICAL CO., PLANT: ABU-SULTAN, ISMAILIA, EGYPTEGYPTORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2011
67NDA/MAL/HDP/0212MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN1G/100MLMEDICAL UNION PHARMACEUTICAL CO., PLANT: ABU-SULTAN, ISMAILIA, EGYPTEGYPTORAL LIQUID ORDINARY SUSPENSIONS 1.0X120.0 ML BOTTLE01/07/2012
68NDA/MAL/HDP/0218ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDTENOL-100ATENOLOL100MGLINCOLN PHARMACEUTICALS LTD ., 10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2007
69NDA/MAL/HDP/0219PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDOLWORM-400ALBENDAZOLE400LINCOLN PHARMACEUTICALS LTD ., 10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X1.0 TABLET BLISTER07/01/2015
70NDA/MAL/HDP/0220ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDZENOCET-10CETIRIZINE10MGLINCOLN PHARMACEUTICALS LTD ., 10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER07/01/2013
71NDA/MAL/HDP/0221DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN250 MG + 250 MGDAWA PHARMACEUTICALS LIMITED, PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
72NDA/MAL/HDP/0222ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDAVIR-200ACYCLOVIR200MGS KANT HEALTHCARE LIMITED, 1802 €“ 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 LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
73NDA/MAL/HDP/0223ABACUS (A) PHARMA LTDABACUS PARENTERAL DRUGS LIMITEDTOPCID-150RANITIDINE150LINCOLN PHARMACEUTICALS LTD ., 10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2005
74NDA/MAL/HDP/0230STRIDES PHARMA SCIENCE LIMITEDDELMAW ENTERPRISES LIMITEDCOMBIARTARTHEMETHER + LUMEFANTRINE20MG +120MGSTRIDES PHARMA SCIENCE LIMITED (STRIDES SHASUN), KRS GARDENS, PLOT 36/7 SURAGAJKKANAHALLI, INDLAWADI CROSS, ANKAL TALUK, BANGALORE SOUTH - 562106, INDIA| UNIVERSAL CORPORATION LIMITED, PLOT NO 13777, PO BOX 1748-00902 KIKUYU CLUB RDINDIAORAL 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
75NDA/MAL/HDP/0232TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.BRANTALOSARTAN POTASSIUM + AMLODIPINE BESILATE50MG + 5MGTORRENT PHARMACEUTICALS LTD .,, AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
76NDA/MAL/HDP/0233MEDOCHEMIE LTDLABOREX UGANDA LIMITEDCEFIMED 400CEFIXIME TRIHYDRATE400MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C, 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0 TABLET BLISTER01/07/2014
77NDA/MAL/HDP/0234MEDOCHEMIE LTDLABOREX UGANDA LIMITEDCEFIMED 200CEFIXIME TRIHYDRATE200MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREACYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X8.0 TABLET BLISTER,1.0X2.0X5.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
78NDA/MAL/HDP/0235MEDOCHEMIE LTDLABOREX UGANDA LIMITEDAXETINE 500CEFUROXIME AXETIL500MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREACYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET STRIP01/07/2014
79NDA/MAL/HDP/0239MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDKOMEFAN 140ARTEMETHER + LUMEFANTRINE20 MG+ 120 MGMYLAN LABORATORIES LTD-, F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY 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
80NDA/MAL/HDP/0250ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDIKONDICLOFENAC1%W/WLINCOLN PHARMACEUTICALS LTD ., 10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT| KESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G CONTAINER01/07/2013
81NDA/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, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
82NDA/MAL/HDP/0253ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTENLOW-5AMLODIPINE BESYLATE5MGLINCO N PHARMACEUTICALS LIMITED, TRIMUL ESTATE KHATRAJ KALOL GUJARAT INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
83NDA/MAL/HDP/0254MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 5BISOPROLOL HEMIFUMARATE5MGMERCK KGAA, 250 FRANKFRUTER STRASSE 250-64293 DARMSTADT| WINTHROP PHARMACEUTICALS(PTY) LTD,, 315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE)GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
84NDA/MAL/HDP/0255M/S HETERO LABS LIMITEDASTRA PHARMA (U) LIMITEDCAPETERO 150CAPECITABINE150MGHETERO LABS (UNIT VI), INDIA, APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET CONTAINER01/07/2015
85NDA/MAL/HDP/0256HETERO LABS LTD ASTRA PHARMA (U) LIMITEDCAPETERO 500CAPECITABINE500MGHETERO LABS (UNIT VI), INDIA, APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X120.0 TABLET CONTAINER01/07/2015
86NDA/MAL/HDP/0257SANOFI AVENTS FRANCELABOREX UGANDA LIMITEDCORDARONEAMIODARONE HYDROCHLORIDE200MGSANOFI WINTHROP INDUSTRIE, LAGRAGE 33565 CARBON BLANC CEDEX FRANCE
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87NDA/MAL/HDP/0266ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZATHINE PENICILLIN INJECTIONBENZATHINE PENICILLIN2.400.000 IUCSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP , NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0 VIAL CARTON01/07/2001
88NDA/MAL/HDP/0269LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-8ONDANSETRON8MGLINCOLN PHARMACEUTICALS LIMITED , 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
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89NDA/MAL/HDP/0270HETERO LABS LTD AIVEEN (U) LIMITEDLEVIN 500MGLEVOFLOXACIN HEMIHYDRATE500MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2013
90NDA/MAL/HDP/0271BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDBETTTETANUS VACCNE ADSORBED40 I.UBIOLOGICAL E LTD, PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078INDIAPARENTERAL ORDINARY AMPOULES 1.0X20.0X10.0 ML AMPOULE,1.0X24.0X10.0 ML AMPOULE,1.0X5.0 ML VIAL (10 DOSES)01/07/2015
91NDA/MAL/HDP/0275GLAXOSMITHKLINE TRADING SERVICES LTD, UNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE400MGGLAXOSMITHKLINE CONSUMER HEALTHCARE S.A (PTY) LIMITED, 39 HAWKINS AVENUE, EPPING INDUSTRIA 1, 7460, CAPE TOWN, SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0 TABLET BLISTER01/07/2011
92NDA/MAL/HDP/0276MICRO LABS LTDLABOREX UGANDA LIMITEDMELANOV 80GLICLAZIDE 80MGMICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
93NDA/MAL/HDP/0278COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 100MGCHLORPROMAZINE HYDROCHLORIDE100MGCOSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/1998
94NDA/MAL/HDP/0283DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN125 MG + 125 MGDAWA PHARMACEUTICALS LIMITED, PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2013
95NDA/MAL/HDP/0290LABORATORY & ALLIED LTDROYAL PHARMA 2011 LIMITEDNATOAMEBENDAZOLE100MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/1997
96NDA/MAL/HDP/0293HETERO LABS LTD AIVEEN (U) LIMITEDDARUNAVIRDARUNAVIR600MGHETERO LABS LTD, 22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE01/07/2014
97NDA/MAL/HDP/0296COSMOS LTDASTRA PHARMA (U) LIMITEDPRAZITEL TABLETSPRAZIQUANTEL600MGCOSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/1998
98NDA/MAL/HDP/0298SAKAR HEALTH CARE PVT .LTDMEDINOVATION ENTERPRISES LTDSEFIXI-50 DRY SYRUPCEFIXIME50MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X60.0 ML BOTTLE01/07/2013
99NDA/MAL/HDP/0300ABACUS (A) PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAB-DOX-100DOXYCYCLINE100MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD, NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA| CHINAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2016
100NDA/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),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA
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101NDA/MAL/HDP/0302ABACUS (A) PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCINAMET-400CIMETIDINE400JIANGSU PENGYAO PHARMACEUTICALS CO. LTD , NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCECHINAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2015
102NDA/MAL/HDP/0303HETERO LABS LTD AIVEEN (U) LIMITEDABACAVIR SULPHATE ABACAVIR SULPHATE300MGHETERO DRUGS LTD, UNIT III , 22-110, IDA, JEEDIMETLAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET CONTAINER01/07/2014
103NDA/MAL/HDP/0306ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDFULVINGRISEOFULVIN500JIANGSU PENGYAO PHARMACEUTICALS CO. LTD, NO. 10 CHAQUAN ROAD,YIXING CITY, CHINACHINAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2015
104NDA/MAL/HDP/0311MARTINDALE PHARMACEUTICALS LTD LABOREX UGANDA LIMITEDFENTANYLFENTANYL CITRATE50MCG/MLMARTINDALE PHARMACEUTICAL LIMITED , BAMPTON ROAD RMM38UG ENGLAND UNITED KINGDOMPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE01/07/2013
105NDA/MAL/HDP/0312SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDCLOXISPA ORAL SOLUTION 125CLOXACILLIN125MG/5MLSPARSH BIO-TECH LTD, PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2013
106NDA/MAL/HDP/0314MARTINDALE PHARMACEUTICALS LTD LABOREX UGANDA LIMITEDSUXAMETHONIUM CHLORIDE SOLUTION FOR INJECTIONSUXAMETHONIUM CHLORIDE50MG/MLMARTINDALE PHARMA , BAMPTON ROAD, HAROLD HILL,ROMFORD,RM3844UNITED KINGDOMPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE01/07/2013
107NDA/MAL/HDP/0318DAWA LIMITEDSUPER MEDIC LTDSABULIN SALBUTAMOL4MGDAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
108NDA/MAL/HDP/0320DAWA LIMITEDSUPER MEDIC LTDDAZOLECLOTRIMAZOLE1%W/W DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2013
109NDA/MAL/HDP/0322MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-5NEBIVOLOL HCL5MGMICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2009
110NDA/MAL/HDP/0326ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDOSTEBONCALCIUM + COLECALCIFEROL250MG + 125 IUARISTO PHARMACEUTICALS PVT LIMITED, PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE01/07/2014
111NDA/MAL/HDP/0335GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDNEOMYCIN SULPHATE CREAM USPNEOMYCIN SULPHATE CREAM USP 0.5%WWKREMOINT PHARMA PVT LTD, B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA INDIATOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE01/07/2013
112NDA/MAL/HDP/0341IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 40TELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGIND SWIFT LTD, GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2014
113NDA/MAL/HDP/0342IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 80TELMISARTAN + HYDROCHLOROTHIAZIDE80MG + 12.5MGIND SWIFT LTD, GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER,3.0X10.0 TABLET BLISTER01/07/2014
114NDA/MAL/HDP/0348ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDXBETABETAMETHASONE SODIUM PHOSPHATE0.1%W/VABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAOPHTHALMIC DROPS 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL01/07/2015
115NDA/MAL/HDP/0349SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDCLAXY 1.2 GCOAMOXICLAV1.2G SWISS PARENTERALS LIMITED UNIT II, PLOT 402, 412-414, KERALA INDUSTRIAL ESTATE, GIDC, NEAR BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA|INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.2 G VIAL01/07/2015
116NDA/MAL/HDP/0350 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCETRIRENCETIRIZINE HYDROCHLORIDE10MGRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2015
117NDA/MAL/HDP/0355SWISS PARENTERALS LTDSHREEJI PHARMACEUTICALS LTD- MITYANABICO VITATHIAMINE HCL + RIBOFLAVIN + PYRIDOXINE HCL + NICOTINAMIDE10MG + 0.1MG + 1MG + 10MGSWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE01/07/2015
118NDA/MAL/HDP/0356DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 50OLEVOFLOXACIN HEMIHYDRATE500MGALLPHAMED PHARMBIL ARZNEIMITTEL GMBH, HILDERBRAND, STR 12-37081, GOTTINGENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2014
119NDA/MAL/HDP/0360ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 20MGESOMEPRAZOLE20MGASTRA ZENECA AB, SODERTALJE, GARTUNAYEGEN, SODERTALJESWEDENORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON01/07/2001
120NDA/MAL/HDP/0362SWISS PARENTERALS LTDSHREEJI PHARMACEUTICALS LIMITEDBUPIBUPIVACAINE5 MG/MLSWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL01/07/2015
121NDA/MAL/HDP/0363BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDAGYCINAZITHROMYCIN250MGBLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0 TABLET BLISTER01/07/2014
122NDA/MAL/HDP/0366BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDAGYCIN 500 AZITHROMYCIN500MGBLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER01/07/2014
123NDA/MAL/HDP/0370MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-HNEBIVOLOL + HYDROCHLOROTHIAZIDE5MG + 12.5MGMICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2010
124NDA/MAL/HDP/0372UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDLEZYNCETLEVOCETIRIZINE 5MGUNICHEM LABORATORIES LIMITED, UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER,5.0X2.0X10.0 TABLET BLISTER01/07/2009
125NDA/MAL/HDP/0376EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-DAMLODIPINE + HYDROCHLOROTHIAZIDE2.5 MG + 12.5 MGEMCURE PHARMACEUTICALS LTD, LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
126NDA/MAL/HDP/0386EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-80ENOXAPARIN SODIUM80MG/ 0.8MLEMCURE PHARMACEUTICALS LTD , PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 ML PRE- FILLED SYRINGE01/07/2014
127NDA/MAL/HDP/0388KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAZUCLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL 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
128NDA/MAL/HDP/0389PT SANBE FARMAMEDVIN PHARMA LIMITEDSANMOL INFUSION IV PARACETAMOL1000MG/100MLPT SANBE FARMA JI INDUSTRI, NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE01/07/2014
129NDA/MAL/HDP/0394LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDDOXYLEBDOXYCYCLINE 100MGLEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2014
130NDA/MAL/HDP/0397EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-LTAMLODIPINE + LOSARTAN POTASSIUM2.5 MG + 50 MGEMCURE PHARMACEUTICALS LTD, LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X3.0X10.0 TABLET BLISTER01/07/2013
131NDA/MAL/HDP/0401FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDL MONTUSLEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM5MG + 10MGFOURRTS (INDIA) LABORATORIES (PVT) LTD, FOURRTS AVENUE, VANDALUR ROADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET STRIP01/07/2015
132NDA/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, MAHARASHTRAINDIAPARENTERAL ORDINARY I V AMPOULES 1.0X2.0X5.0X1.0 ML AMPOULE01/07/2013
133NDA/MAL/HDP/0405NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDCHEMLETLETROZOLE2.5MGNEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
134NDA/MAL/HDP/0406NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDEVATOCINOXYTOCIN10 I.U./ ML NEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY I V AMPOULES 1.0X2.0X5.0X1.0 ML AMPOULE01/07/2015
135NDA/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, MAHARASHTRAINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL01/07/2013
136NDA/MAL/HDP/0408MSN LABORATORIES PRIVATE LIMITED,STAR PHARMACEUTICALS LTDALGIC - PACECLOFENAC + PARACETAMOL100 MG + 500 MGMSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
137NDA/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, MAHARASHTRAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL01/07/2013
138NDA/MAL/HDP/0410MSN LABORATORIES PRIVATE LIMITEDSTAR PHARMACEUTICALS LTDLDNIL 20ROSUVASTATIN CALCIUM 20MGMSN LABORATORIES LTD, PLOT N0.42, ANRICH INDUSTRIAL ESTATEINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
139NDA/MAL/HDP/0411BAYER PHARMA AGSURGIPHARM (U) LIMITEDJADELLE SINELEVONORGESTREL150MGBAYER OY, PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS 1.0X10.0X1.0X2.0X75.0 MG IMPLANT01/07/2003
140NDA/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, MAHARASHTRAINDIAPARENTERAL ORDINARY I V AMPOULES 1.0X2.0X5.0X1.0 ML AMPOULE01/07/2013
141NDA/MAL/HDP/0415MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDRELEXDIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM CHLORIDE+SODIUM CITRATE+MENTHOL14.03MG+138MG+57.03MG+0.90MGTORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/1997
142NDA/MAL/HDP/0418ASTRA ZENECA MACNAUGHTON LIMITEDKOMBIGLYZE XR 5MG/1000SAXAGLIPTIN + METFORMIN5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP., 4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE,1.0X4.0X7.0 TABLET BLISTER01/07/2013
143NDA/MAL/HDP/0419ASTRAZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 2.5MG/1000MGSAXAGLIPTIN + METFORMIN2.5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP., 4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE01/07/2013
144NDA/MAL/HDP/0421MSN LABORATORIES PRIVATE LIMITED,STAR PHARMACEUTICALS LTDPREGASAFE 150PREGABALIN150MGMSN LABORATORIES LTD, PLOT NO.42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2014
145NDA/MAL/HDP/0422GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPARAFLAMIBUPROFEN + PARACETAMOL100MG + 162.5MG /5MLAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
146NDA/MAL/HDP/0423GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRAMTRAMADOL50MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2013
147NDA/MAL/HDP/0424COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 25MGCHLORPROMAZINE25MGCOSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/1998
148NDA/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 NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
149NDA/MAL/HDP/0428MICRO LABS LTD LABOREX UGANDA LIMITEDMICROMOX-400MOXIFLOXACIN400MGMICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X5.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2013
150NDA/MAL/HDP/0429ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDFLEXON MRIBUPROFEN + PARACETAMOL + CHLORZOXAZONE400MG + 325MG + 250MGARISTO PHARMACEUTICALS PVT. LIMITED, PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY TABLETS 10.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2014
151NDA/MAL/HDP/0430ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDARISTO ACECLO PLUSACECLOFENAC+PARACETAMOL100MG+500MGARISTO PHARMACEUTICALS PVT LIMITED, PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X15.0X10.0 TABLET BLISTER01/07/2013
152NDA/MAL/HDP/0432FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDK MAC ORAL SOLUTIONPOTASSIUM CITRATE + MAGNESIUM CITRATE22MG + 7.5MGFOURRTS INDIA LABORATORIES PVT. LIMITED, VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE01/07/2013
153NDA/MAL/HDP/0433PT SAMBE FARMAMEDVIN PHARMA LIMITEDPROANES MCT/LCTPROPOFOL1%W/VPT SANBE FARMA JI INDUSTRI, NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY I V AMPOULES 1.0X5.0X20.0 ML AMPOULE01/07/2014
154NDA/MAL/HDP/0434LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDPROHIBINGASTRO-RESISTANT OMEPRAZOLE CAPSULES BP 2020 MGLEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP01/07/2010
155NDA/MAL/HDP/0447PT SANBE FARMAMEDVIN PHARMA LIMITEDSANEXON®125METHYLPREDNISOLONE SODIUM SUCCINATE125MG/VIALPT SANBE FARMA UNIT 3., JL INDUSTRI CIMAREME NO.8 PADALARANG 40533 BANDUNGINDONESIAPARENTERAL ORDINARY DRY VIALS 1.0X125.0 MG VIAL + 1*2ML AMPOULE OF WFI01/07/2014
156NDA/MAL/HDP/0449PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD GRANULESCYANOCOBALAMIN5MCGSTEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL SOLID ORDINARY GRANULES 1.0X10.0X5.0 G SACHET01/07/2013
157NDA/MAL/HDP/0453PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD LIQUIDAMINO ACIDS + MULTIVITAMINSMULTI INGREDIENTS STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE01/07/2013
158NDA/MAL/HDP/0454PT SANBE FARMAMEDVIN PHARMA LIMITEDLEVOCIN INFUSIONLEVOFLOXACIN HEMIHYDRATE 500 MGPT SANBE FARMA JI INDUSTRI, NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE01/07/2014
159NDA/MAL/HDP/0456LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDMETROLEB METRONIDAZOLE125MG/5MLLEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2014
160NDA/MAL/HDP/0460ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE7.5MG/MLARISTO PHARMACEUTICALS PVT. LIMITED, PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X15.0 ML BOTTLE01/07/2009
161NDA/MAL/HDP/0463GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTOPHEN PHENYTOIN100MGAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2011
162NDA/MAL/HDP/0467DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTDCURAMOL PLUSPARACETAMOL/CAFFEINE500MG/60MGDAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 50.0X2.0 TABLET STRIP01/07/1997
163NDA/MAL/HDP/0470NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVOMIX 30 FLEXPENINSULIN ASPART100I.U/MLNOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA, AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL| NOVO NORDISK A/S , NOVO ALLE DK-2880 BAGSVAERD| NOVO NORDISK PRODUCTION SAS, 45 AVENUE D€™ORLEANS, 28000 CHARTRES, FRANCEDENMARKPARENTERAL ORDINARY DRY PRE-FILLED PENS 1.0X5.0X3.0 ML PREFILLED PEN01/07/2014
164NDA/MAL/HDP/0471NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVORAPID FLEXPENINSULIN ASPART100 I.U/MLNOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA, AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL| NOVO NORDISK PRODUCTION SAS, 45 AVENUE D€™ORLEANS, 28000 CHARTRES, FRANCE| NOVO NORDISK A/S , NOVO ALLE DK-2880 BAGSVAERDDENMARKPARENTERAL ORDINARY PRE-FILLED PENS 1.0X5.0X3.0 ML PREFILLED PEN01/07/2014
165NDA/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 LIMITED, S/NO 105-110, MANJARI BUDRUK, TAL - HAVEIL, PUNE 412307 - INDIA| SERUM INSTITUTE OF INDIA LTD, 212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1X0.5 ML VIAL, 1X1 ML VIAL, 1X10 ML VIAL01/07/2015
166NDA/MAL/HDP/0475LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDTINI-500TINIDAZOLE500MGLINCOLN PHARMACEUTICALS LIMITED , 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X25.0X4.0 TABLET BLISTER01/07/2015
167NDA/MAL/HDP/0477LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-4ONDANSETRON4MGLINCOLN PHARMACEUTICALS LIMITED , 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2014
168NDA/MAL/HDP/0482LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDAZILEB-500 AZITHROMYCIN500MGLEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0X3.0 TABLET BLISTER01/07/2014
169NDA/MAL/HDP/0489LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDCEBAY-200 DTCEFIXIME200MGLEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0 TABLET BLISTER01/07/2014
170NDA/MAL/HDP/0491ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCHLOR EYE DROPSCHLORAMPHENICOL0.5% W/VABACUS PARENTERAL DRUGS LTD, PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
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UGANDAOPHTHALMIC DROPS 1.0X5.0 ML VIAL,1.0X10.0 ML VIAL01/07/2013
171NDA/MAL/HDP/0493MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDPRASUSAFE 10PRASUGREL10MGMSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
172NDA/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
INDIAORAL SOLID ORDINARY CAPSULES 1.0X20.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER01/07/2014
173NDA/MAL/HDP/0497LABORATORY&ALLIED LTDROYAL PHARMA 2011 LIMITEDKEMOXYL DRY SUSPENSIONAMOXYCILLIN TRIHYDRATE125MG/5MLLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
| 		KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2014
174NDA/MAL/HDP/0502STEDMAN PHARMACEUTICALS LTDVEERAM HEALTHCARE (U) LIMITEDDREZ GARGLEIODINATED POVIDONE2%W/VSTEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
175NDA/MAL/HDP/0507FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDFILDILOL 12.5CARVEDILOL12.5 MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103,
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INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
176NDA/MAL/HDP/0509FOURRTS (INDIA) LABORATORIES (PVT) LTDDELMAW ENTERPRISES LIMITEDFILDILOL 25CARVEDILOL25MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
177NDA/MAL/HDP/0510GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID-600LINEZOLID600MGGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X4.0 TABLET STRIP01/07/2004
178NDA/MAL/HDP/0512FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 10ATORVASTATIN CALCIUM10MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
179NDA/MAL/HDP/0515FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 20ATORVASTATIN20MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
180NDA/MAL/HDP/0518RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCYCLORENACICLOVIR200MGRENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2014
181NDA/MAL/HDP/0520FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 40ATORVASTATIN CALCIUM40MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER01/07/2014
182NDA/MAL/HDP/0521ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDPAN 40 PANTOPRAZOLE SODIUM 40MGSANCE LABORATORIES PVT LTD (VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA.INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1X10 TABLET BLISTER, 1X3X10 BLISTER AMPOULE, 1X3X10 TABLET BLISTER01/07/2013
183NDA/MAL/HDP/0526LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDAMILEB- 25 AMITRIPTYLINE25MG LEBEN LABORATORIES PVT. LTD, PLOT NO. L-4, PHASE-III, MIDC,
AKOLA€“ 444 104 (MS).
INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
184NDA/MAL/HDP/0531LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDENDERM-GMCLOBETASOL PROPIONATE + GENTAMYCIN + MICONAZOLE NITRATE0.05%W/W + 0.10%W/W + 2.0%W/WLEBEN LABORATORIES PVT. LTD., PLOT NO. L-4, PHASE €“III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIATOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE,1.0X15.0 G TUBE01/07/2014
185NDA/MAL/HDP/0538MICRO LABS LTD LABOREX UGANDA LIMITEDXONADINE 180FEXOFENADINE HYDROCHLORIDE180 MGMICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2013
186NDA/MAL/HDP/0541MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 120FEXOFENADINE HYDROCHLORIDE120MGMICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
187NDA/MAL/HDP/0542DAWA LIMITED SUPER MEDIC LTDPHENBITALPHENOBARBITAL30MGDAWA LTD, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
188NDA/MAL/HDP/0543UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLIMERYL 2GLIMEPIRIDE2MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
189NDA/MAL/HDP/0544MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN PLUSACECLOFENAC + PARACETAMOL100 MG + 500 MGMICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
190NDA/MAL/HDP/0547NAARI LTDUNITED HEALTHCARE DISTRIBUTORS LTDMISO-KAREMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITED, PLOT NO. 14-16 &55-57, SECTOR-5, IIE, PANTNAGAR, RUDRAPUR-263153, DIST. U.S. NAGAR, UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0 TABLET BLISTER (COMBIPACK),1.0X3.0X4.0 TABLET BLISTER01/07/2013
191NDA/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 SECURITYJORDANORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
192NDA/MAL/HDP/0550DAWA LIMITEDSUPER MEDIC LTDDA-ZEPAMDIAZEPAM5MGDAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2014
193NDA/MAL/HDP/0553BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDEQUIRABRABIES ANTISERUM1000IU/ 5MLBHARAT SERUMS AND VACCINES LIMITED,, PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY VIALS 1.0X1.0X5.0 ML VIAL (5 DOSE VIAL)01/07/2013
194NDA/MAL/HDP/0555HOVID BHD UNITED HEALTHCARE DISTRIBUTORS LTDCARZEPINCARBAMAZEPINE200MGHOVID BHD, LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
195NDA/MAL/HDP/0558ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABGENTA EYE DROPS GENTAMICIN SULPHATE 0.3% W/V ABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE,1.0X5.0 ML VIAL01/07/2014
196NDA/MAL/HDP/0559HOVID BHD MEDICAL ACCESS (UGANDA) LIMITEDDIABETMIN RETARDMETFORMIN HYDROCHLORIDE850MGHOVID BHD, LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIAMALAYSIAORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
197NDA/MAL/HDP/0563IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDEZO 40ESOMEPRAZOLE MAGNESIUM 40MGIND-SWIFT-LTD,, GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSIINDIAORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
198NDA/MAL/HDP/0568 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDFLUOXIRENFLUOXETINE20MGRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
199NDA/MAL/HDP/0569ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCELLRIDIN LINCTUSPHOLCODINE10MG/5MLKOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY SYRUPS 1.0X90.0 ML BOTTLE01/07/2014
200NDA/MAL/HDP/0570BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDTETGLOB 250 I.UHUMAN TETANUS IMMUNOGLOBULIN 250IUBHARAT SERUMS AND VACCINES LIMITED,, PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY I M VIALS 1.0X1.0X2.0 ML VIAL (1 DOSE VIAL)01/07/2013
201NDA/MAL/HDP/0571ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL KAOPEC LIGHT KAOLIN + PECTIN (CITRUS)1G + 20MG/5MLKOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X120.0 ML BOTTLE01/07/2015
202NDA/MAL/HDP/0573ABACUS PHARMA (A) LTD.UNITED HEALTHCARE DISTRIBUTORS LTDAXCEL PARACETAMOL-250 PARACETAMOL250MG/5MLKOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2014
203NDA/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.INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X3.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER01/07/2013
204NDA/MAL/HDP/0576GLAXOSMITHKLINE TRADING SERVICES LTD, UNITED HEALTHCARE DISTRIBUTORS LTDDUODARTDUTASTERIDE + TAMSULOSIN0.5MG + 0.4MGCATALENT GERMANY SCHONDORF GMBH , STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANYGERMANYORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE CONTAINER01/07/2015
205NDA/MAL/HDP/0580KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUCAPMULTINGREDIENTMULTINGREDIENTKAMPALA PHARMECEUTICALS INDUSTRIES LTD., PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
206NDA/MAL/HDP/0582ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDACECLO SERAACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE100MG + 500MG + 15MGARISTO PHARMACEUTICALS PVT LTD, VILLAGE: MAKHNUMAJRA P.O. BHUD BADDI DISTRIC: SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2015
207NDA/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) 173205INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
208NDA/MAL/HDP/0585CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DOMPERONDOMPERIDONE1MG/MLCADILA PHARMACEUTICALS LTD., 1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE01/07/2013
209NDA/MAL/HDP/0586CADILA PHARMACEUTICALS LIMITEDAAFIYA (A) LIMITEDONSETTONDANSETRON2MG/MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE01/07/2013
210NDA/MAL/HDP/0587CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCADIGRELCLOPIDOGREL75MGCADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
211NDA/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) 173205INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
212NDA/MAL/HDP/0593ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDPANTOP-DPANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE CAPSULES20MG+10MGARISTO PHARMACEUTICALS PVT LTD ., MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY ENTERIC-COATED CAPSULES 1.0X10.0X10.0 CAPSULE STRIP,1.0X3.0X10.0 CAPSULE STRIP01/07/2014
213NDA/MAL/HDP/0595ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNOFORNIDAZOLE + OFLOXACIN500MG + 200MGARISTO PHARMACEUTICALS PVT LTD--, VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2015
214NDA/MAL/HDP/0596MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-HTELMISARTAN/HYDROCHLOROTHIAZIDE40MG/12.5MGMICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP01/07/2011
215NDA/MAL/HDP/0598INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLIPICURE-20ATORVASTATIN20MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION), CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER01/07/2003
216NDA/MAL/HDP/0599MICRO LABS LIMITEDLABOREX UGANDA LIMITEDGRAMOCEF-O-400CEFIXIME400MGMICROLABS LIMITED, PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2013
217NDA/MAL/HDP/0600DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 6.25CARVEDILOL6.25MGARTESAN PHARMA GMBH & CO. KG , WENDLANDSTRABE 1,29439 LUCHOW,GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
218NDA/MAL/HDP/0603MEDLEY PHARMACEUTICALS LTDEUROPA HEALTHCARE (U) LTDGROMIN SYRUPMULTI-INGREDIENTMULTI-INGREDIENTMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/1999
219NDA/MAL/HDP/0605DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 25CARVEDILOL25MGARTESAN PHARMA GMBH & CO. KG , WENDLANDSTRABE 1,29439 LUCHOW,GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
220NDA/MAL/HDP/0609DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDCLOPI-DENK 75CLOPIDOGREL BESYLATE75MGARTESAN PHARMA GMBH & CO. KG , WENDLANDSTRABE 1,29439 LUCHOW,GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
221NDA/MAL/HDP/0610ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDPYLOR KIT LANSOPRAZOLE DELAYED RELEASE + CLARITHROMYCIN+ TINIDAZOLE30MG + 250MG + 500MGLINCOLN PHARMACEUTICALS LTD ., 10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)01/07/2016
222NDA/MAL/HDP/0614GLAXOSMITHKLINE TRADING SERVICES LTD, UNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID125MG/5ML + 31.25MG/5MLSMITHKLINE BEECHAM PHARMACEUTICALS,, CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1998
223NDA/MAL/HDP/0617ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDSILVEXSILVER SULFADIAZINE + CHLORHEXIDINE1%W/W + 0.2%W/WLINCOLN PHARMACEUTICALS LTD ., 10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2014
224NDA/MAL/HDP/0619ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD10 GLUCOSE10%W/V ABACUS PARENTERAL DRUGS LTD, PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE01/07/2013
225NDA/MAL/HDP/0621HETERO LABS LTD AIVEEN (U) LIMITEDALZERDONEPEZIL HYDROCHLORIDE10MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
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226NDA/MAL/HDP/0622ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDTENOL-50ATENOLOL 50MG LINCOLN PHARMACEUTICALS LTD ., 10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
227NDA/MAL/HDP/0623ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDGELCIDMAGNESIUM SULPHATE50%W/VLINCOLN PHARMACEUTICALS LTD-, 11 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X5.0X10.0 ML AMPOULE,1.0X10.0X5.0X5.0 ML AMPOULE IN BLISTER PACK,1.0X5.0 ML AMPOULE IN BLISTER PACK01/07/2015
228NDA/MAL/HDP/0626KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCARDIPAC-10AMLODIPINE BESILATE10MGKPI INDUSTRIES (1996) LTD, PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0X10.0 TABLET BLISTER01/07/2015
229NDA/MAL/HDP/0627KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAMOXIKIDAMOXICILLIN TRIHYDRATE125MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD, PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2015
230NDA/MAL/HDP/0633ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIPROCINCIPROFLOXACIN0.3%W/VABACUS PARENTERAL DRUGS LTD, PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL01/07/2013
231NDA/MAL/HDP/0634MEDLEY PHARMACEUTICALS EUROPA HEALTHCARE (U) LTDTRISOLIVANDROGRAPHOLIDES/TRICHOLINE CITRATE50MCG+50MG/MLMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE01/07/2014
232NDA/MAL/HDP/0635GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-AMINAMINOPHYLLINE100MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER01/07/2009
233NDA/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.INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0 TABLET BLISTER01/07/2014
234NDA/MAL/HDP/0637NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDZUDICORTFUSIDIC ACID + BETAMETHASONE VALERATE20MG + 1MG/GNABIQASIM INDUSTRIES (PVT) LIMITED, 17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTANPAKISTANTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2014
235NDA/MAL/HDP/0638PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDABLOL-5 EYE DROPSTIMOLOL MALEATE0.5% W/VABACUS PARENTERAL DRUGS LTD, PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS 1.0X10.0 ML VIAL01/07/2013
236NDA/MAL/HDP/0639NEM LABORATORIES (PVT) LTDRENE PHARMACY LTDRHEUMATIC CREAMMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATEINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/1997
237NDA/MAL/HDP/0652NVS KENYA LTD SURGIPHARM (U) LIMITEDGALVUSVILDAGLIPTIN50MGNOVARTIS PHARMA STEIN AG, SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X4.0X14.0 TABLET BLISTER01/07/2009
238NDA/MAL/HDP/0654NVS KENYA LTD SURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG/500MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR, GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER01/07/2013
239NDA/MAL/HDP/0657NVS KENYA LTD SURGIPHARM (U) LIMITEDGALVUS MET VILDAGLIPTIN / METFORMIN50MG / 850MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR, GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER01/07/2013
240NDA/MAL/HDP/0658NVS KENYA LTD SURGIPHARM (U) LIMITEDGALVUS MET VILDAGLIPTIN/ METFORMIN50MG/1000MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR, GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER01/07/2013
241NDA/MAL/HDP/0665HETERO LABS LTD AIVEEN (U) LIMITEDIRBIS 150IRBESARTAN150MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2013
242NDA/MAL/HDP/0666HETERO LABS LTD AIVEEN (U) LIMITEDIRBIS-H 300IRBESARTAN300MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2013
243NDA/MAL/HDP/0667ABACUS PHARMA (A) LTD.UNITED HEALTHCARE DISTRIBUTORS LTDAXEL MICONAZOLEMICONAZOLE NITRATE2%W/WKOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE,1.0X15.0 G TUBE01/07/2013
244NDA/MAL/HDP/0668CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDTELI 40TELMISARTAN40MGCADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
245NDA/MAL/HDP/0669ABACUS PHARMA (A) LTD.UNITED HEALTHCARE DISTRIBUTORS LTDAXEL FUNGICORT CREAMMICONAZOLE NITRATE + HYDROCORTISONE2% W/W + 1% W/WKOTRA PHARMA SDN BDN, 1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE,1.0X15.0 G TUBE01/07/2013
246NDA/MAL/HDP/0670GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFLUNAZ-200FLUCONAZOLE200MGAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY CAPSULES 1.0X4.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER,10.0X4.0 CAPSULE STRIP01/07/2014
247NDA/MAL/HDP/0671ABACUS PHARMA (A) LTD.UNITED HEALTHCARE DISTRIBUTORS LTDAXCEL LIGNOCAINELIDOCAINE2%W/WKOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE01/07/2014
248NDA/MAL/HDP/0674GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODAPS-100DAPSONE100MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER01/07/2013
249NDA/MAL/HDP/0675ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL METRONIDAZOLE 400METRONIDAZOLE400MGKESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT| KOTRA PHARMA, BHD
1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA
MALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2015
250NDA/MAL/HDP/0677GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDOPAMETMETHYLDOPA250MGAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
251NDA/MAL/HDP/0678ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL HYDROCORTISONE CREAMHYDROCORTISONE1%W/WKESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT| KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X5.0 G TUBE01/07/2014
252NDA/MAL/HDP/0679GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMEFENA-250 CAPSULESMEFENAMIC ACID250MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2013
253NDA/MAL/HDP/0681EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDELAXIM 40TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR)40MG/VIALGENNOVA BIOPHARMACEUTICALS LIMITED, BLOCK 1, PLOT NO. P-1 AND P-2, ITBT PARK, PHASE II, MIDC, HINJAWADI, PUNE - 411057INDIAPARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL , 1*8 ML VIAL OF WFI01/07/2013
254NDA/MAL/HDP/0688GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDHBBHYOSCINE BUTYLBROMIDE10MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
255NDA/MAL/HDP/0689GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONALNALIDIXIC ACID500MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
256NDA/MAL/HDP/0690MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHEALTHEASE CREAMBECLOMETHASONE DIPROPRIONATE + PHENYLEPHRINE HCL + LIGNOCAINE HCL + CHLOROCRESOL0.025%W/W + 0.1%W/W + 2.5%W/W + 0.1%W/WTORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE01/07/2014
257NDA/MAL/HDP/0692DAWA LIMITED SUPER MEDIC LTDDAWACLOX -250 CLOXACILLIN SODIUM250MGDAWA LIMITED , BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2015
258NDA/MAL/HDP/0693DAWA LIMITEDSUPER MEDIC LTDMOXACIL -250 AMOXYCILLIN TRIHYDRATE250MGDAWA PHARMACEUTICALS LIMITED, PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2014
259NDA/MAL/HDP/0694GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDT ZINC-20 TABLETSZINC SULPHATE20MGAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CARTON01/07/2013
260NDA/MAL/HDP/0696HETERO LABS LTD ASTRA PHARMA (U) LIMITEDRITONAVIRRITONAVIR100MGHETERO LABS LTD, 22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2014
261NDA/MAL/HDP/0700ZYDUS LIFESCIENCES LTD.ABACUS PHARMA (AFRICA) LIMITEDVAXIRAB NINACTIVATED RABIES VIRUS(PITMAN MOORE STRAIN)>2.5 I.UZYDUS LIFESCIENCES LIMITED, SURVEY NO. 417, 419 & 420, SARKHEJ - BAVLA NATIONAL HIGHWAY NO. 8A, VILLAGE - MORAIYA, TALUKA - SANAND, DIST. AHMEDABAD - 382 210, GUJARAT STATE - INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0 ML VIAL + 1ML AMPOULE OF WFI(1 DOSE VIAL)01/07/2015
262NDA/MAL/HDP/0702ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDSEPTOCINSTREPTOMYCIN SULPHATE1GMREYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINACHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X1.0 G VIAL,1.0X100.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL01/07/2014
263NDA/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 506INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE01/07/2013
264NDA/MAL/HDP/0704HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDM-FLOXMOXIFLOXACIN HYDROCHLORIDE400MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | HETERO LABS LTD-UNIT II & III BADDI THE NALAGARH DIST SOLAN H.P | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X5.0 TABLET BLISTER01/07/2013
265NDA/MAL/HDP/0705LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDACICLOVIRACICLOVIR5%W/WLINCOLN PHARMACEUTICAL LIMITED, TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE01/07/2011
266NDA/MAL/HDP/0706INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 5ROSUVASTATIN5MGINTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
267NDA/MAL/HDP/0710INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 20ROSUVASTATIN20MGINTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
268NDA/MAL/HDP/0712GLAXOSMITHKLINE TRADING SERVICES LTD, UNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE100MG/5MLASPEN BAD OLDESLOE GMBH, INDUSTRIESTRASSE, INDUSTRIESTRASSE 32-36, 23843 BAD OLDESLOEGERMANYORAL LIQUID ORDINARY SUSPENSIONS 1.0X20.0 ML BOTTLE01/07/1997
269NDA/MAL/HDP/0713DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 20PANTOPRAZOLE SODIUM SESQUIHYDRATE20MGALLPHAMED PHARMBIL ARZNEIMITTEL GMBHHILDERBRAND, STR 12-37081, GOTTINGEN | GERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER01/07/2013
270NDA/MAL/HDP/0715DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGALLPHAMED PHARMBIL ARZNEIMITTEL GMBHHILDERBRAND, STR 12-37081, GOTTINGEN | GERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER12/13/2023
271NDA/MAL/HDP/0718LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-2GLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG + 500MGLINCOLN PHARMACEUTICALS L.T.D, TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER01/07/2014
272NDA/MAL/HDP/0719WOCKHARDT LTDKAMCARE PHARMA LIMITEDWEPOX 4000RECOMBINANT HUMAN ERYTHROPOIETIN4000 I.UWOCKHARDT LIMITED -, WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.4 ML PRE- FILLED SYRINGE01/07/2011
273NDA/MAL/HDP/0720STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDJUSDEE 400 DROPSCOLECALCIFEROL400 I.U/MLSTEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL LIQUID ORDINARY DROPS 1.0X15.0 ML BOTTLE01/07/2013
274NDA/MAL/HDP/0721MISSION PHARMAMETRO PHARMACEUTICALS LIMITEDARH-AARTEMETHER80MG/MLLINCOLN PHARMACEUTICAL LTD TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIAPARENTERAL ORDINARY I M AMPOULES 1.0X2.0X3.0X1.0 ML AMPOULE,1.0X1.0X6.0 ML AMPOULE01/07/2000
275NDA/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. INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE01/07/2014
276NDA/MAL/HDP/0726TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDT DOL RAPIDTRAMADOL HYDROCHLORIDE 50MG TROIKAA PHARMACEUTICALS LTD, SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2014
277NDA/MAL/HDP/0727MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDSTOMACH FIT SYRUPBISMUTH AMMONIUM CITRATE+BELLADONA DRY EXTRACT+THYMOL+MENTHOL140MG+9MG+0.15MG+0.2/5MLTORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X225.0 ML BOTTLE01/07/2013
278NDA/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.INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X3.0 TABLET BLISTER01/07/2013
279NDA/MAL/HDP/0731IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE 50/135ARTESUNATE + AMODIAQUINE50/135MGIPCA LABORATORIES LIMITED , SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X3.0 TABLET BLISTER01/07/2013
280NDA/MAL/HDP/0734AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDOMMED -20OMEPRAZOLE20MGMEDICO REMEDIES PVT LIMITED, 8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA|INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE STRIP01/07/2015
281NDA/MAL/HDP/0736MEDOCHEMIE LTDLABOREX UGANDA LIMITEDMABRON 50TRAMADOL HYDROCHLORIDE50MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREACYPRUSORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
282NDA/MAL/HDP/0740MEDOCHEMIE LTDLABOREX UGANDA LIMITEDCOTRIMCO-TRIMOXAZOLE960MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREACYPRUSORAL SOLID ORDINARY TABLETS 1.0X17.0X6.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
283NDA/MAL/HDP/0741MEDOCHEMIE LTDLABOREX UGANDA LIMITEDMEDOCIPRINCIPROFLOXACIN500MG MEDOCHEMIE LTD (FACTORY AZ), 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS, INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUSCYPRUSORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
284NDA/MAL/HDP/0742MEDOCHEMIE LTDLABOREX UGANDA LIMITEDBROTMETFORMIN HYDROCHLORIDE500MGMEDOCHEMIE (FACTORY AZ)., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
285NDA/MAL/HDP/0745CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDTELI 80TELMISARTAN80MGCADILA PHARMACEUTICALS LIMITED, 1389, TRABAD ROAD, DHOLKA 387 810, DISTRICT AHMEDABAD, GUJARAT, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
286NDA/MAL/HDP/0746COSMOS LTDASTRA PHARMA (U) LIMITEDDTS-Z KIT TABLET-ZINC, SACHET-NACL + KCL + TRISODIUM CITRATE + ANHYDROUS GLUCOSETABLET-54.89MG , SACHET 1.3G + 0.75G + 1.45G + 6.75GCOSMOS LIMITED, KENYA, RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X4.0X10.3 G SACHET + 1.0X10.0 TABLET BLISTER01/07/2013
287NDA/MAL/HDP/0748BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 15MGRIVAROXABAN15MGBAYER PHARMA AG 51368 LEVERKUSEN, BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X14.0 TABLET BLISTER01/07/2013
288NDA/MAL/HDP/0750BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 20MGRIVAROXABAN20MGBAYER PHARMA AG 51368 LEVERKUSEN, BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X14.0 TABLET BLISTER01/07/2013
289NDA/MAL/HDP/0751MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWINACECLOFENAC100MGMICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
290NDA/MAL/HDP/0754DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDTORAS DENK 10TORASEMIDE10MG DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
291NDA/MAL/HDP/0759MICRO LABS LTDLABOREX UGANDA LIMITEDCOTRIMOXAZOLECOTRIMOXAZOLE960MGMICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2011
292NDA/MAL/HDP/0764UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORVADIL 5AMLODIPINE5MGUNICHEM LABORATORIES LIMITED UNIT II, VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP01/07/2011
293NDA/MAL/HDP/0765SHANGHAI DAHUA PHARMACEUTICAL CO., LTD.UNITED HEALTHCARE DISTRIBUTORS LTDLEVOPLANTLEVONORGESTREL75MGSHANGHAI DAHUA PHARMACEUTICAL CO. LTD, CHANG ZENG FARM, CHONGMING COUNTY, SHANGHAICHINAPARENTERAL RETARD IMPLANTS 1.0X10.0X2.0 ROD IMPLANT01/07/2010
294NDA/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 407 | CHINA | PARENTERAL ORDINARY DRY VIALS 1.0X50.0X500.0 MG VIAL01/07/2013
295NDA/MAL/HDP/0772MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPREGABALIN MEGA 150PREGABALIN150MGMSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2016
296NDA/MAL/HDP/0775MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPREGABALIN MEGA 75PREGABALIN75MGMSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2014
297NDA/MAL/HDP/0776FREDUN PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDFREMOL TABLETSPARACETAMOL TABLETS500MGFREDUN PHARMACEUTICALS LTD, 14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1999
298NDA/MAL/HDP/0781TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRICOLDPARACETAMOL/PHENYLEPHRINE HYDROCHLORIDE/CAFFEINE ANHYDROUS/CHLORPHENIRAMINE500MG/10MG/30MG/2MGTRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER01/07/2013
299NDA/MAL/HDP/0794REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTDHEALTHCARE LTD.AMYGYDEXTOBRAMYCIN/DEXAMETHASONE3MG+1MG/MLREMINGTON PHARMACEUTICALS (PVT) LTD, 18KM, MULTAN ROAD, LAHORE 53800, PAKISTANPAKISTANOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE01/07/2014
300NDA/MAL/HDP/0795GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPEN-250PHENOXYMETHYL PENICILLIN POTASSIUM250MGMILAN LABORATORIES (INDIA) PVT LTD ., PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI)INDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
301NDA/MAL/HDP/0798HETERO LABS LTD AIVEEN (U) LIMITEDAMLOSIN 10AMLODIPINE BESILATE10MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2013
302NDA/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 BLISTER01/07/2016
303NDA/MAL/HDP/0811MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN -SRACECLOFENAC200MGMICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
304NDA/MAL/HDP/0816DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 2 GLIMEPIRIDE 2MG DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
305NDA/MAL/HDP/0821DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 3 GLIMEPIRIDE 3MG DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
306NDA/MAL/HDP/0822ABACUS (A) PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLOXCIN-500CLOXACILLIN SODIUM500MGREYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINACHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X0.5 G VIAL,1.0X100.0X0.5 G VIAL,1.0X10.0X0.5 G VIAL01/07/2014
307NDA/MAL/HDP/0824I CARE PHARMA LIMITEDVITACARE LTDCLOXACILLINCLOXACILLIN250MGMEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/1997
308NDA/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 | INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2010
309NDA/MAL/HDP/0830MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 25 MCGLEVOTHYROXINE SODIUM25 MCGMERCK KGAA - , FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X1.0X30.0 TABLET BLISTER,1.0X4.0X25.0 TABLET BLISTER01/07/2015
310NDA/MAL/HDP/0831I CARE PHARMA LIMITEDVITACARE LTDAMPICILLIN CAPSULESAMPICILLIN250MGMEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2010
311NDA/MAL/HDP/0832MERCK UNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 100MCGLEVOTHYROXINE100MCGMERCK KGAA - , FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER01/07/2015
312NDA/MAL/HDP/0834LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMI-6DOXYLAMINE SUCCINATE & PYRIDOXINE HYDROCHLORIDE10MG + 10MGLINCOLN PHARMACEUTICALS LIMITED., TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2013
313NDA/MAL/HDP/0835GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBISBISACODYL5MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2013
314NDA/MAL/HDP/0836LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCALBONE-500CALCIUM CARBONATE + COLECALCIFEROL1250MG + 250 I.ULINCOLN PHARMACEUTICALS LIMITED , 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2012
315NDA/MAL/HDP/0842LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSACSECNIDAZOLE1000MGLINCOLN PHARMACEUTICALS LIMITED , 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X2.0 TABLET BLISTER01/07/2013
316NDA/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
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER,1.0X5.0X1.0X10.0 TABLET BLISTER01/07/2013
317NDA/MAL/HDP/0850LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLCT KITLANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE30MG + 250MG + 500MGLINCOLN PHARMACEUTICALS LIMITED , 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)01/07/2012
318NDA/MAL/HDP/0853 SUN PHARMACEUTICAL INDUSTRIES LIMITED -STAR PHARMACEUTICALS LTDBRUSTAN GELIBUPROFEN + LEVOMENTHOL5% W/W+ 3%W/WSUN PHARMACEUTICAL IND. LTD, PLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X50.0 G CONTAINER01/07/2012
319NDA/MAL/HDP/0855HETERO LABS LTD AIVEEN (U) LIMITEDLAZINELEVOCETIRIZINE DIHYDROCHLORIDE5MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2013
320NDA/MAL/HDP/0857GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V6 VAGINAL TABLETSCLOTRIMAZOLE100MGGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAVAGINAL TABLETS 1.0X6.0 PESSARY STRIP01/07/2000
321NDA/MAL/HDP/0858ASTRA ZENECA MACNAUGHTON LIMITEDPLENDILFELODIPINE5MGASTRAZENECA SWEDEN OPERATIONS, ASTRAZENECA SWEDEN OPERATIONS SE-151 85 SODERTALJE| ASTRAZENECA PHARMACEUTICAL CO LTD., NO. 2 HUANGSHAN ROAD, WUXI, 214028, JIANGSUCHINA| SWEDENORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2001
322NDA/MAL/HDP/0864HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDPANTIN-40PANTOPRAZOLE SODIUM40 MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301 | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2013
323NDA/MAL/HDP/0866GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID LINEZOLID2MG/MLAMANTA HEALTHCARE LIMITED, PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
324NDA/MAL/HDP/0869SAKAR HEALTH CARE PVT .LTDMEDINOVATION ENTERPRISES LTDLARTRMARTEMETHER80MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | PARENTERAL ORDINARY I M AMPOULES 1.0X6.0X1.0 ML AMPOULE01/07/2013
325NDA/MAL/HDP/0870TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROY-KPHYTOMENADIONE10MG/MLTROIKAA PHARMACEUTICALS LIMITED, THOL, DIST. MEHSANA-382728, GUJARAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE01/07/2010
326NDA/MAL/HDP/0871SAKAR HEALTH CARE PVT .LTDMEDINOVATION ENTERPRISES LTDDEXADEXAMETHASONE SODIUM4MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 2.0X6.0X2.0 ML VIAL01/07/2013
327NDA/MAL/HDP/0873GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDOXYTOCIN INJECTIONOXYTOCIN 10I.U/MLSAKAR HEALTH CARE PVT LTD10/13 CHONGODAR SARKHEJ BAVLA ROAD DIST AHEMABAD 382213 GUJARATI | LABORATE PHARMACEUTICALS INDIA LIMITED - UNIT II, 31, RAJBAN ROAD, NAIWALA, PAONTA SAHIB, DISTT. SIRMOUR, HIMACHAL PRADESH - INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE27/03/2019
328NDA/MAL/HDP/0874LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDLEBASMA-4SALBUTAMOL4MGLEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X20.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
329NDA/MAL/HDP/0877LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDANTAGIT DS GEL MINT FLAVOURDRIED ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X170.0 ML BOTTLE01/07/2007
330NDA/MAL/HDP/0879COSMOS LTD.ASTRA PHARMA (U) LIMITEDTRIBEES FORTE FILM COATED TABLETSTHIAMINE + PYRIDOXINE + CYANOCOBALAMIN200MG + 50MG +1000MCGCOSMOS LIMITED, KENYA, RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER01/07/2012
331NDA/MAL/HDP/0882MERCK UNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/2.5MGMETFORMIN + GLIBENCLAMIDE500MG + 2.5MGMERCK SANTE S.A.S, CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOYFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER01/07/2012
332NDA/MAL/HDP/0883MERCK UNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/5MGMETFORMIN + GLIBENCLAMIDE500MG + 5MGMERCK SANTE S.A.S, CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOYFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER01/07/2012
333NDA/MAL/HDP/0889ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDNSSODIUM CHLORIDE + GLUCOSE0.9%W/V + 5% W/VABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE01/07/2012
334NDA/MAL/HDP/0894HETERO LABS LTD AIVEEN (U) LIMITEDGIAGRA 100SILDENAFIL CITRATE100MGHETERO 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 1.0X4.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER01/07/2014
335NDA/MAL/HDP/0895VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHYORTH SODIUM HYALURONATE10MG/1MLVIRCHOW BIOTECH PVT, LTD, SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X2.0 ML PRE- FILLED SYRINGE01/07/2015
336NDA/MAL/HDP/0897VIRCHOW HEALTHCARE PVT LTDLEGIT MEDEQ 2007 LIMITEDDEBRIDACEPAPAIN + UREA521700UNITS+100MG/GVIRCHOW BIOTECH PVT, , SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANAINDIATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE01/07/2015
337NDA/MAL/HDP/0898HETERO LABS LTD AIVEEN (U) LIMITEDLOSAGEN 50 LOSARTAN POTASSIUM50MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
338NDA/MAL/HDP/0899VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDVIRIAXONECEFTRIAXONE1GINJECTCARE PARENTERALS PVT. LTD., PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 10 ML VIAL WFI01/07/2013
339NDA/MAL/HDP/0902GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPINE SR NIFEDIPINE20MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
340NDA/MAL/HDP/0906VIRCHOW HEALTHCARE PVT LTDLEGIT MEDEQ 2007 LIMITEDIONSILSILVER NITRATE0.2%W/WVIRCHOW BIOTECH PVT, , SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANAINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE01/07/2015
341NDA/MAL/HDP/0911VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHEALACE RECOMBINANT HUMAN PLATELET DERIVED GROWTH FACTOR -B100MCG/GVIRCHOW BIOTECH PVT, LTD, SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE01/07/2015
342NDA/MAL/HDP/0913NOVARTIS PHARMA SURGIPHARM (U) LIMITEDFEMARA LETROZOLE3MGNORVATIS PHARMA STEIN AG, SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/1997
343NDA/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 PRADESHINDIAPARENTERAL ORDINARY VIALS 1.0X3.0 ML VIAL,1.0X3.0 ML PREFILLED PEN01/07/2015
344NDA/MAL/HDP/0920TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY HEAVYBUPIVACAINE HYDROCHLORIDE5MG/ML TROIKAA PHARMACEUTICALS LTD ., SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X5.0X4.0 ML VIAL01/07/2012
345NDA/MAL/HDP/0926MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-375AMOXICILLIN +CLAVULANATE POTASSIUM250MG + 125MGMICRO LABS LIMITED., PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP01/07/2004
346NDA/MAL/HDP/0928AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINSTACLOP 75CLOPIDOGREL75MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.| AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP01/07/2013
347NDA/MAL/HDP/0941AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHAAZITHROMYCIN200MG/5MLAJANTA PHARMA LIMITED, 31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X15.0 ML BOTTLE01/07/2013
348NDA/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 AREAKENYAORAL LIQUID ORDINARY LIQUIDS 1.0X60.0 ML BOTTLE01/07/2013
349NDA/MAL/HDP/0951NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDNORADSTERILE NORADRENALINE CONCENTRATE2MG/2MLNEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY S C AMPOULES 1.0X5.0X2.0 ML AMPOULE01/07/2013
350NDA/MAL/HDP/0952NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDEFECTALCEFTRIAXONE1GNEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL01/07/2013
351NDA/MAL/HDP/0953NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDCIZCANCISPLATIN10MG/10MLNEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL01/07/2013
352NDA/MAL/HDP/0954NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDANAWINBUPIVACAINE50MG/20MLNEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL RETARD OTHER VIALS 1.0X20.0 ML VIAL01/07/2013
353NDA/MAL/HDP/0957MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDLYRED SYRUPVITAMINE A + VITAMINE E ACETATE + ASCORBIC ACID + SELENIUM + ZINC2500 IU + 10 IU + 50MG + 35MCG + 3MGTORQUE PHARMACEUTICALS PVT LTD, ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE01/07/2012
354NDA/MAL/HDP/0959AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDARTEFAN DISPERSIBLE 20/120ARTEMETHER + LUMEFANTRINE20MG + 120MGAJANTA PHARMA LTD ., B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL 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
355NDA/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, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2005
356NDA/MAL/HDP/0981HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCLOFENAC SR TABLETS DICLOFENAC SODIUM100MGHOVID BERHAD (CHEMOR SITE)-, LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIAMALAYSIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2008
357NDA/MAL/HDP/0988CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCADITOR 20ATORVASTATIN20MGCADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
358NDA/MAL/HDP/0995LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDFLUCOMOLPARACETAMOL + PHENYLEPHRINE HCL + DEXTROMETHORPHAN HBR + CHLORPHENIRAMINE MALEATE250MG + 5MG + 10MG + 2MGLINCOLN PHARMACEUTICALS LTD-, TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2014
359NDA/MAL/HDP/0999 EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCESUNITED HEALTHCARE DISTRIBUTORS LTDTHIOEVATHIOTIC ACID600MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES, 176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER01/07/2014
360NDA/MAL/HDP/1000TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROYCURIUMATRACURIUM10MG/MLTROIKAA PHARMACEUTICALS LIMITED, THOL, DIST. MEHSANA-382728, GUJARAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X3.0 ML AMPOULE,1.0X5.0X2.5 ML AMPOULE01/07/2012
361NDA/MAL/HDP/1001 EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCESUNITED HEALTHCARE DISTRIBUTORS LTDTHIOEVATHIOTIC ACID300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES, 176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
362NDA/MAL/HDP/10033MEDOPHARMPLANET PHARMACEUTICALS UGANDA LTDEMCARCARBAMAZEPINE200 MGMEDOPHARM, NO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKAINDIAORAL 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
363NDA/MAL/HDP/10036MEDOPHARMPLANET PHARMACEUTICALS UGANDA LTDMEDOMOLPARACETAMOL500 MGMEDOPHARM, NO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKAINDIAORAL 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
364NDA/MAL/HDP/10038MEDOPHARM PRIVATE LIMITEDVITACARE LIMITEDCLEDOMOX 312.5 MG/5 MLAMOXILLIN TRIHYDRATE + POTASSIUM CLAVULANATE312.5 MG/5 MLMEDOPHARM PVT LIMITED, NO. 50 KAYARAMBEDU VILLAGE, GUDUVANCHERY-603202INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML CONTAINER14/07/2022
365NDA/MAL/HDP/10040NAME AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITEDAFRICURE PHARMACEUTICALS U LIMITEDCARBAMAZEPINE TABLETS USP 200 MGCARBAMAZEPINE200 MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. |INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER19/07/2022 00:00
366NDA/MAL/HDP/10041PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDPUMPINOXESOMEPRAZOLE MAGNESIUM TRIHYDRATE20MGPHARMA INTERNATIONAL CO. LTD , AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAANJORDANORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X1.0X14.0 TABLET CONTAINER06/07/2022
367NDA/MAL/HDP/10045PHARMACTIV FZCOHEALTHCARE LTD.SURGITECCEFOTAXIME SODIUM1 G/VIALSURGE LABORATORIES (PVT) LTD.,,-10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN. | PAKISTAN | PARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 1*5ML, WFI IN A CLEAR GLASS AMPOULE19/07/2022
368NDA/MAL/HDP/10048JOSHPA AFRICA LTDAAFIYA (A) LIMITEDAAFISUNATE 60 MGARTESUNATE60 MG/VIALSANJAR PHARMACEUTICALS LIMITED, SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X60.0 MG VIAL + 1*1ML, CLEAR GLASS AMPOULE OF 5% W/V SODIUM BICARBONATE + 1*5ML CLEAR GLASS AMPOULE OF 0.9% W/V SODIUM CHLORIDE19/07/2022
369NDA/MAL/HDP/10049ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDERYTHROMYCIN ESTOLATE ORAL SUSPENSION USP 125 MG/5MLERYTHROMYCIN ESTOLATE125 MG/5MLSCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE19/07/2022
370NDA/MAL/HDP/10050SERUM INSTITUTE OF INDIA PVT LTDNORVIK ENTERPRISES LIMITEDROTAVIRUS VACCINE, LIVE ATTENUATED (ORAL) ROTASIIL LIQUIDLIVE ATTENUATED BOVINE - HUMAN ROTAVIRUS REASSORTANT [G1, G2, G3, G4 AND G9]?105.6 FFU / SEROTYPE PER DOSE (2 ML)SERUM INSTITUTE OF INDIA PVT LTD ., 212/2, HADAPSAR, PUNE- 411028, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X2.0 ML VIAL, 1.0X50.0X2.0 ML VIAL19/07/2022
371NDA/MAL/HDP/10052UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDHI DEE 5000 IUCHOLECALCIFEROL5,000IUUNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDANJORDANORAL SOLID ORDINARY OTHER CAPSULES 1.0X1.0X30.0 CAPSULE CONTAINER19/07/2022
372NDA/MAL/HDP/10056MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDAVARINSIMETHICONE+ ALVERINE CITRATE300 MG + 60 MGMEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILANDTHAILANDORAL SOLID ORDINARY OTHER CAPSULES 1.0X5.0X1.0X10.0 CAPSULE BLISTER19/07/2022
373NDA/MAL/HDP/1006MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRIPRIDE-2GLIMEPIRIDE + PIOGLITAZONE+ METFORMIN2MG+15MG+500MGMICRO LABS LTD 92 SIPCOT , 92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
374NDA/MAL/HDP/10060EMCURE PHARMACEUTICALS LTD -HARLEYS UGANDA LIMITEDVIROPILDOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE50 MG + 300 MG + 300 MGEMCURE PHARMACEUTICALS LIMITED, PLOT NO. P-2. ITBT PARK, PHASE II, MIDC, HINJWADI PUNE 411057, MHARASHTRA STATE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1X1X30 TABLET CONTAINER,19/07/2022
375NDA/MAL/HDP/10061AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINSTACLOP PLUSCLOPIDOGREL + ASPIRIN75 MG + 75 MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER19/07/2022
376NDA/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,INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X90.0 TABLET BOTTLE,1.0X30.0 TABLET BOTTLE19/07/2022
377NDA/MAL/HDP/10066CIPLA LTD.ABACUS PHARMA (AFRICA) LIMITEDFEMPROLETROZOLE2.5MGCIPLA 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-GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER19/07/2022
378NDA/MAL/HDP/10067TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRITINITINIDAZOLE500MGTRIVENI FORMULATIONS LTD-PLOT NO. 52,53,54,63,62,64 ALEAP INDUSTRIUAL ESTATE SARAMPALLI VIJAYWADA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X25.0X4.0 TABLET BLISTER19/07/2022
379NDA/MAL/HDP/10069MICRO LABS LIMITEDLABOREX UGANDA LIMITEDOPELAN ODT 5OLANZAPINE5 MGMICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126INDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X3.0X10.0 TABLET BLISTER14/07/2022
380NDA/MAL/HDP/1007COSMOS LTDASTRA PHARMA (U) LIMITEDZINCOS DISPERSIBLE TABLETS 20MGZINC SULPHATE20MGCOSMOS LIMITED, KENYA, RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
381NDA/MAL/HDP/10072EMCURE PHARMACEUTICALS LTD -HARLEYS UGANDA LIMITEDINBECABACAVIR SULPHATE + DOLUTEGRAVIR SODIUM + LAMIVUDINE600 MG + 50 MG + 300 MGEMCURE PHARMACEUTICALS LIMITED, PLOT NO. P-2. ITBT PARK, PHASE II, MIDC, HINJWADI PUNE 411057, MHARASHTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS 1X1X30 TABLET CONTAINER,14/07/2022
382NDA/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 PAKISTANINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X120.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE14/07/2022
383NDA/MAL/HDP/10083THE SEARLE COMPANY LIMITEDSURGIPHARM (U) LIMITEDMORCETESCITALOPRAM OXALATE20 MGSEARLE PAKISTAN LTD.., F-319, S.I.T.E., OPP. KESC POWER STATION, KARACHIPAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER14/07/2022
384NDA/MAL/HDP/10084M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDSEDAFOLPROPOFOL10 MG/ MLASPIRO PHARMA LIMITED-SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | PARENTERAL ORDINARY VIALS 1.0X1.0X200.0 MG VIAL14/07/2022
385NDA/MAL/HDP/10086ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDNEOMICLAV-DSAMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM(200 MG + 28.5 MG)/5 MLCHIROS PHARMA, VILLAGE LOHARON, P.O. GHATTI, DISTT. - SOLAN, HIMACHAL PRADESH - INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X60.0 ML BOTTLE14/07/2022
386NDA/MAL/HDP/1009TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY 0.5%BUPIVACAINE5MG/ML TROIKAA PHARMACEUTICALS LTD ., SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL01/07/2012
387NDA/MAL/HDP/10091ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDPG-150PREGABALIN150 MGZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARATINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER14/07/2022
388NDA/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 LTD, PLOT 34, SEC 8A, IIE, SIDCUL, HARIDWAR-269403 UTTARAKHAND INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE18/07/2022
389NDA/MAL/HDP/10097ALKEM LABORATORIES LTDABACUS PHARMA (AFRICA) LIMITEDNULOC 20ESOMEPRAZOLE MAGNESIUM20 MGEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER18/07/2022
390NDA/MAL/HDP/10098ALKEM LABORATORIES LTDABACUS PHARMA (AFRICA) LIMITEDNULOC 40ESOMEPRAZOLE MANESIUM40 MGEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER18/07/2022
391NDA/MAL/HDP/10100HETERO LABS LTD AIVEEN (U) LIMITEDPANTINPANTOPRAZOLE SODIUM SESQUIHYDRATE40 MG/VIALASPIRO PHARMA LIMITED-SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL18/07/2022
392NDA/MAL/HDP/10101AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDVILDARIL 50VILDAGLIPTIN50 MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER18/07/2022
393NDA/MAL/HDP/10103PINNACLE LIFE SCIENCE PVT. LTDABACUS PHARMA (AFRICA) LIMITEDCOLDPILPARACETAMOL +PHENYLEPHRINE HYDROCHLORIDE + CHLORPEHNAMINE MALEATE650 MG + 5 MG + 2 MGPINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER18/07/2022
394NDA/MAL/HDP/10104IND-SWIFT LIMITEDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT 40TELMISARTAN40 MGIND-SWIFT LIMITED /, VILL-JAWAHARPUR, OFF NH21, DERABASSI DIST: MOHALI, PUNJABINDIATABLETS (COATED1.0X3.0X10.0 TABLET BLISTER06/07/2022
395NDA/MAL/HDP/10105IND-SWIFT LIMITEDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT 80TELMISARTAN80 MGIND-SWIFT LIMITED /, VILL-JAWAHARPUR, OFF NH21, DERABASSI DIST: MOHALI, PUNJABINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER06/07/2022
396NDA/MAL/HDP/10112KESAR PHARMAABACUS PHARMA (AFRICA) LIMITEDKESKETOKETOCONAZOLE2 % W/WKESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIATOPICAL EXTERNAL CREAMS 1.0X1.0X20.0 G TUBE14/07/2022
397NDA/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), INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 TABLET BLISTER14/07/2022
398NDA/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 PARKUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET CONTAINER06/07/2022
399NDA/MAL/HDP/10117FAES FARMA S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVENOSMILHIDROSMIN200 MGFAES FARMA SA, MAXIMO AGUIRRE 14. 48940 LEIOA €“ SPAINSPAINORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER06/07/2022
400NDA/MAL/HDP/1012NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDLOX 2%LIDOCAINE2% W/VNEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY OTHER VIALS 1.0X50.0 ML VIAL,1.0X20.0 ML VIAL01/07/2013
401NDA/MAL/HDP/10129HETERO LABS LTD AIVEEN (U) LIMITEDDARUNAVIR AND RITONAVIR TABLETS 400 MG/50 MGDARUNAVIR ETHANOLATE + RITONAVIR400 MG + 50 MGHETERO LABS PRIVATE LIMITED UNIT III, SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE,INDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE18/07/2022
402NDA/MAL/HDP/1013NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDTHIOSOLTHIOPENTAL SODIUM500MGNEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X20.0 ML VIAL01/07/2013
403NDA/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
KENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0X4.0 TABLET BLISTER01/07/2015
404NDA/MAL/HDP/10140UNICHEM LABORATORIES LIMITEDˆŠEUROPA HEALTHCARE (U) LTDALDROL 5DONEPEZIL HYDROCHLORIDE5MGUNICHEM LABORATORIES BADI-UNIT II, VILLAGE BHATAULI, BADDI HIMACHAL PRADESH, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER06/07/2022
405NDA/MAL/HDP/10141UNICHEM LABORATORIES LIMITEDˆŠEUROPA HEALTHCARE (U) LTDALDROL 10DONEPEZIL HYDROCHLORIDE10MGUNICHEM LABORATORIES BADI-UNIT II, VILLAGE BHATAULI, BADDI HIMACHAL PRADESH, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER06/07/2022
406NDA/MAL/HDP/10144VIRCHOW BIOTECH PVT LTD, SURGIPHARM (U) LIMITEDCLASIPROBACILLUS CLAUSII SPORES2 X 10^9 SPORES/ 5 MLVIRCHOW BIOTECH PRIVATE LIMITED, SURVEY NO. 172 PART, GAGILLAPUR, QUTHBULLPUR, RR DISTRICT, TELANGANA-500043INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X2.0X5.0 ML AMPOULE,1.0X5.0X5.0 ML AMPOULE,1.0X10.0X5.0 ML AMPOULE06/07/2022
407NDA/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-GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X1.0 TABLET BLISTER12/13/2023
408NDA/MAL/HDP/10146ATCO LABORATORIES LIMITEDHARLEYS UGANDA LIMITEDUMBILICA GELCHLORHEXIDINE GLUCONATE4%W/WATCO LABS LTD,, B-18, S.I.T.E, KARACHIPAKISTANTOPICAL EXTERNAL GELS AND SOLS 1.0X10.0 G TUBE18/07/2022
409NDA/MAL/HDP/10148AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDRALEF 60ETORICOXIB60MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X7.0 TABLET BLISTER18/07/2022
410NDA/MAL/HDP/10149AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDRALEF 90ETORICOXIB90MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X7.0 TABLET BLISTER18/07/2022
411NDA/MAL/HDP/10150AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDRALEF 120ETORICOXIB120MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X7.0 TABLET BLISTER18/07/2022
412NDA/MAL/HDP/10151S KANT HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDFUNGARINMICONAZOLE2%W/WS KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA.INDIAORAL TOPICAL GELS AND SOLS 1.0X1.0X30.0 G TUBE06/07/2022
413NDA/MAL/HDP/10164ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDASPIRIN TABLETSACETYLSALICYCLIC ACID300MGELYS CHEMICAL INDUSTRIES LIMITED,, OFF ENTERPRISE ROAD, OPP HILLLOCK-INN ROAD B, INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET STRIP,1.0X200.0 TABLET TIN,1.0X1000.0 TABLET TIN02/09/2022
414NDA/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 AREAKENYAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X14.0 G SACHET,1.0X28.0 G SACHET02/09/2022
415NDA/MAL/HDP/10169ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDORODARSULFADOXINE+PYRIMETHAMINE500MG+25MGELYS CHEMICAL INDUSTRIES LIMITED,, OFF ENTERPRISE ROAD, OPP HILLLOCK-INN ROAD B, INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X30.0X3.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER02/09/2022
416NDA/MAL/HDP/1017ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDELYCLOXAMPICILLIN/CLOXACILLIN125MG/125MGELYS CHEMICAL INDUSTRIES LIMITED, ROAD B€™, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2015
417NDA/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 AMPOULE04/10/2022
418NDA/MAL/HDP/10176ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDCLINDAMYCIN HYDROCHLORIDE CAPSULES USP 300 MGCLINDAMYCIN HYDROCHLORIDE300 MGCIRON DRUGS PHARMACEUTICALS PRIVATE LIMITED, PLOT NO. 35-37, 43-45, CFC-B, DEWAN UDHYOG NAGAR, ALIYALI, PALGHAR €“ 401404, MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER29/09/2022
419NDA/MAL/HDP/1018KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM CHLORCHLORAMPHENICOL250MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD., PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL 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
420NDA/MAL/HDP/10182MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDCYCLOSERINE 250 MGCYCLOSERINE250 MGMYLAN LABORATORIES LIMITED, NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER04/10/2022
421NDA/MAL/HDP/10183 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDTEXAKINDTRANEXAMIC ACID500MG/5MLMANKIND PHARMA LIMITED, UNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X4.0X5.0 ML AMPOULE09/09/2022
422NDA/MAL/HDP/10185MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTURBOVAS-10ROSUVASTATIN CALCIUM10MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0X10.0 TABLET BLISTER09/09/2022
423NDA/MAL/HDP/10186PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDAARLOFLOX OZOFLOXACIN + ORNIDAZOLE200 MG + 500 MGPINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0X10.0 TABLET BLISTER09/09/2022
424NDA/MAL/HDP/10188PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDAARLEFLOX 750LEVOFLOXACIN HEMIHYDRATE750 MGPINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER09/09/2022
425NDA/MAL/HDP/10189PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDETRICOX 120ETORICOXIB120 MGPINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
426NDA/MAL/HDP/10192INFUGEN PHARMA PVT. LTD.TATA UGANDA LIMITEDINFUTAXIM 1 GMCEFOTAXIME SODIUM1 G/ VIALINNOVA CAPTAB PVT. LTD, 1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)| ZEISS PHARMACEUTICALS PRIVATE LIMITED, PLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.)INDIAPARENTERAL RETARD DRY VIALS 1.0X1.0X1.0 G VIAL09/09/2022
427NDA/MAL/HDP/10194MS PHARMA JORDAN CO.LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDBETOLINABUPIVACAINE HYDROCHLORIDE0.5%W/VMS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE.JORDANPARENTERAL ORDINARY VIALS 1.0X5.0X20.0 ML VIAL03/10/2022
428NDA/MAL/HDP/10196CONCEPT PHARMACEUTICAL LTDJEET PHARMACEUTICALS LIMITEDPANTEC-DSRPANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE40 MG + 30 MGCONCEPT PHARMACEUTICALS LIMITED-KISHANPUR JAMALPUR ROORKEE DIST HARIDWAR -247667 UTTARAKHAND, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER29/09/2022
429NDA/MAL/HDP/10197CENTURION LABORATORIES PVT. LTD. BIOGEN PHARMA LIMITEDLEVOZINELEVOCETIRIZINE DIHYDROCHLORIDE5 MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER29/09/2022
430NDA/MAL/HDP/10199MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDGOFEN 200IBUPROFEN200 MGMEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILANDTHAILANDORAL SOLID ORDINARY OTHER CAPSULES 1.0X6.0X1.0X1.0X10.0 CAPSULE BLISTER09/09/2022
431NDA/MAL/HDP/1020LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDPA-12PARACETAMOL SUSTAINED RELEASE1000MGLINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIAINDIAORAL SOLID RETARD LAYERED TABLETS 1.0X10.0X1.0X12.0 TABLET BLISTER01/07/2012
432NDA/MAL/HDP/10201PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDETRICOX 60ETORICOXIB60 MGPINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
433NDA/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 INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER,1.0X30.0 CAPSULE CONTAINER09/09/2022
434NDA/MAL/HDP/10208MS PHARMA JORDAN CO.LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDKENZOPRAZOLESOMEPRAZOLE SODIUM40MG PER VIALMS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE.JORDANPARENTERAL ORDINARY DRY VIALS 1.0X10.0X40.0 MG VIAL03/10/2022
435NDA/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 1.0X2.5 ML BOTTLE29/09/2022
436NDA/MAL/HDP/10211PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDSPAZNOLDICLOFENAC SODIUM + PARACETAMOL + CHLORZOXAZON50 MG + 325 MG + 250 MGPINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER09/09/2022
437NDA/MAL/HDP/10212PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDSPASNIL PMEFENAMIC ACID + PARACETAMOL500 MG + 325 MGPINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER29/09/2022
438NDA/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) | INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER10/02/2023
439NDA/MAL/HDP/10218BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDCOMIT-100SILDENAFIL CITRATE100 MGBLISS GVS PHARMA LIMITED, 10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER09/09/2022
440NDA/MAL/HDP/10219BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDCOMIT-50SILDENAFIL CITRATE50 MGBLISS GVS PHARMA LIMITED, 10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER09/09/2022
441NDA/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, EGYPTEGYPTORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2013
442NDA/MAL/HDP/10225LUKAS LAB LTDNOVOMED HEALTHCARE LIMITEDLUSNAT 60ARTESUNATE60 MGBLISS INDAS LIFESCIENCE P. LTD.., PLOT 73-76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMANINDIAPARENTERAL 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
443NDA/MAL/HDP/10226LUKAS LAB LTDNOVOMED HEALTHCARE LIMITEDLUSNAT 120ARTESUNATE120 MGBLISS INDAS LIFESCIENCE P. LTD.., PLOT 73-76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMANINDIAPARENTERAL 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 VIAL29/08/2023
444NDA/MAL/HDP/1023MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDZINNIA PLEVONORGESTREL + ETHINYLESTRADIOL 150MCG + 30MCGMYLAN LABORATORIES LIMITED.-, PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.| MYLAN LABORATORIES LIMITED.., PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213INDIAORAL SOLID ORDINARY TABLETS 1.0X28.0 TABLET BLISTER,3.0X28.0 TABLET BLISTER01/07/2013
445NDA/MAL/HDP/10234 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDTERBINAFORCE 250TERBINAFINEHYDROCHLORIDE250 MGMANKIND PHARMA LIMITED, UNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
446NDA/MAL/HDP/10235BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDLOFNAC GELLINSEED OIL + DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + MENTHOL3.00%W/W + 1.16% W/W + 10.00%W/W + 5.00%W/WKREMOINT PHARMA PVT LTD PLANT II, B-8, ADDITIONAL AMBERNATH MIDC, AMBERNATH (EAST) DIST. THANE 421506INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X1.0X30.0 G TUBE09/09/2022
447NDA/MAL/HDP/10238CCL PHARMACEUTICALS (PVT.)LTD.HARLEYS UGANDA LIMITEDNEO-KLARCLARITHROMYCIN500MGCCL PHARMACEUTICALS (PVT) LTD-62- INDUSTRIAL ESTATE, KOT LAKHPHAT, LAHORE- 54770, PAKISTAN |PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER19/09/2022 00:00
448NDA/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, CHINACHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER09/09/2022
449NDA/MAL/HDP/10242EMCURE PHARMACEUTICALS LTD -HARLEYS UGANDA LIMITEDINSTGRADOLUTEGRAVIR SODIUM50MGEMCURE PHARMACEUTICALS LIMITED, PLOT NO. P-2. ITBT PARK, PHASE II, MIDC, HINJWADI PUNE 411057, MHARASHTRA STATE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE09/09/2022
450NDA/MAL/HDP/10246 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLENDESDESLORATADINE5MGGLENMARK PHARMACEUTICALS LIMITED, PLOT NO. S - 7, COLVALE, INDUSTRIAL ESTATE COLVALE, BARDEZ 403513, GOA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER19/09/2022
451NDA/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 AURANGABADINDIAOPHTHALMIC DROPS 1.0X1.0X2.5 ML BOTTLE09/09/2022
452NDA/MAL/HDP/10250JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSINUTAB SINUS PAIN EXTRA STRENGTHCODEINE PHOSPHATE +CHLORPHENIRAMINE MALEATE +PSEUDOEPHEDRINE HYDROCHLORIDE + PARACETAMOL10 MG + 2 MG + 30 MG + 500 MGJOHNSON & JOHNSON (PTY) LTD, 241 MAIN ROAD, RETREAT, 7945, CAPE TOWNSOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X1.0X12.0 TABLET BLISTER09/09/2022
453NDA/MAL/HDP/10251THE UNITED PHARMACEUTICALS MFG, CO. LTD,WIDE SPECTRUM ENTERPRISES (U) LIMITEDCITADONEBETAMETHASONE0.6 MG/5 MLUNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDANJORDANORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X100.0 ML BOTTLE09/09/2022
454NDA/MAL/HDP/10257MS PHARMA JORDAN CO.LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDFENTEX®PHENYTOIN250MG/5MLMS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE.JORDANPARENTERAL ORDINARY VIALS 1.0X10.0X5.0 ML VIAL19/09/2022
455NDA/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 CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
456NDA/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 CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
457NDA/MAL/HDP/10260MICRO LABS LIMITEDLABOREX UGANDA LIMITEDOPELAN ODT 10OLANZAPINE10MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X3.0X10.0 TABLET BLISTER19/09/2022
458NDA/MAL/HDP/10265MYLAN LABORATORIES LIMITED-KIMSY MEDS LTDMYVORCON 200 MGVORICONAZOLE200 MGMYLAN LABORATORIES LTD ., F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X15.0 TABLET BLISTER19/09/2022
459NDA/MAL/HDP/10272WOCKHARDT LTDKAMCARE PHARMA LIMITEDPOWERCEF SCEFTRIAXONE SODIUM + SULBACTAM SODIUM1.5 GM /VIALZEISS PHARMACEUTICALS PRIVATE LIMITED-PLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.5 G VIAL + 1.0X1.0X10ML AMPOULE OF WFI03/10/2022
460NDA/MAL/HDP/10280INDCHEMIE HEALTH SPECIALITIES PVT. LTD.NUMED STORES SMC LIMITEDZENOXIM 500CEFUROXIME AXETIL500 MGINDCHEMIE HEALTH SPECIALITIES PVT. LTD, VILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER09/09/2022
461NDA/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), THANEINDIAORAL SOLID ORDINARY TABLETS 1.0X7.0X1.0X6.0 TABLET BLISTER09/09/2022
462NDA/MAL/HDP/10282 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMUPIWAYSMUPIROCIN2.0 W/WNEXT WAVE, RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P)INDIATOPICAL EXTERNAL OINTMENTS 1.0X1.0X10.0 G TUBE09/09/2022
463NDA/MAL/HDP/10283DAWA LIMITED-SUPER MEDIC LTDDAZOLECLOTRIMAZOLE100MGDAWA LIMITED, PLOT NO. 7879/8 BABADOGO ROAD, RUARAKA P. O. BOX 16633-00620 NAIROBI, KENYAKENYAVAGINAL TABLETS 1.0X1.0X6.0 PESSARY BLISTER09/09/2022
464NDA/MAL/HDP/10287DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDVILDA DENK 50 MGVILDAGLIPTIN50 MG DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER03/10/2022
465NDA/MAL/HDP/10290KESAR PHARMASWASTIK PHARMACEUTICAL LTDPHENYTOIN TABLETS BP 100 MGPHENYTOIN SODIUM100 MGKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT |INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER29/09/2022 00:00
466NDA/MAL/HDP/10293BIOLOGICAL E. LIMITED GITTOES PHARMACEUTICALS LIMITEDTYPHOID CONJUGATE VACCINE (MONOVALENT)TYPHOID VI POLYSACCHARIDE CONJUGATED TO 16.7 µG - 100 µG OF CRM19725 µG /(0.5 ML)DOSEBIOLOGICAL E. LIMITED , PLOT NO. 1, BIOTECH PARK, PHASE-II, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL-MALKAJGIRI DISTRICT, TELENGANA STATE, 500078 - INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X48.0X5.0 DOSE VIAL,1.0X48.0X1.0 DOSE VIAL25/07/2024
467NDA/MAL/HDP/10295EAST AFRICAN (INDIA) OVERSEASROYAL PHARMA 2011 LIMITEDRO-AMICLOXAMPICILLIN TRIHYDRATE + CLOXACILLIN SODIUM250 MG + 250 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 CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER29/09/2022
468NDA/MAL/HDP/10296LUPIN LIMITED-AIVEEN (U) LIMITEDRIFAMPIN, ISONIAZID, PYRAZINAMIDE, ETHAMBUTOL HYDROCHLORIDE TABLETS USP150/75/400/275MGRIFAMPIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL HYDROCHLORIDE150MG + 75MG + 400MG + 275MGLUPIN LTD, A-28/1, M.I.D.C., CHIKALTHANA, AURANGABAD-431210, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X24.0X14.0 TABLET BLISTER09/09/2022
469NDA/MAL/HDP/10298ZOTA HEALTHCARE LTDHARLEYS UGANDA LIMITEDCOXZOTA 90ETORICOXIB90 MGZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
470NDA/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, MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X9.0 TABLET BLISTER01/07/2014
471NDA/MAL/HDP/10303MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDAPZIN-5DAPAGLIFLOZIN5 MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
472NDA/MAL/HDP/10304MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDAPZIN-10DAPAGLIFLOZIN10 MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
473NDA/MAL/HDP/10306SWISS PARENTERALS LTDSHREEJI PHARMACEUTICALS LIMITEDOMEZOLEOMEPRAZOLE SODIUM40 MGSWISS PARENTERALS LIMITED (UNIT-1), 808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X40.0 MG VIAL + 1.0X1.0X10.0ML AMPOULE OF WFI02/06/2021
474NDA/MAL/HDP/10307ZOTA HEALTHCARE LTDHARLEYS UGANDA LIMITEDDESLOZED-5DESLORATADINE5 MGZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER09/09/2022
475NDA/MAL/HDP/10310ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDZINRO INFUSIONORNIDAZOLE500MG/100MLABACUS PARENTERAL DRUGS LIMITED, PLOT 114, BLOCK 191, KINGAUGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML BOTTLE09/09/2022
476NDA/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,INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X120.0 TABLET BOTTLE09/09/2022
477NDA/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,INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE09/09/2022
478NDA/MAL/HDP/10314AFRICURE PHARMACEUTICALS (INDIA) PVT. LTDAFRICURE PHARMACEUTICALS U LIMITEDSPIRONOLACTONE TABLETS BP 25 MGSPIRONOLACTONE25MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793), PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER19/09/2022
479NDA/MAL/HDP/10323AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDXELTINTOFACITINIB CITRATE5MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
480NDA/MAL/HDP/10325MEDLEY PHARMACEUTICALS LTDEUROPA HEALTHCARE (U) LTDONCETCETIRIZINE DIHYDROCHLORIDE5MG/5MLMEDLEY PHARMACEUTICALS LTD-PLOT 18 & 19 SURVEY NO. 378/7&8, 379/2&3 ZARI CAUSEWAY ROAD, KACHIGAM DAMAN-396210, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE19/09/2022
481NDA/MAL/HDP/1033FAES FARMA S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDYNAMOGENGLUTODINE (CYPROHEPTADINE ALPHA- KETOGLUTARATE) + ARGININE ASPARTATE3MG +1GFAES FARMA, S.A , MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYASPAINORAL LIQUID ORDINARY LIQUIDS 1.0X20.0X10.0 ML SACHET01/07/2015
482NDA/MAL/HDP/10336BIOLOGICAL E. LIMITEDGITTOES PHARMACEUTICALS LIMITEDMEASLES AND RUBELLA VACCINE (LIVE) (ATTENUATED, FREEZE DRIED)MEASLES VIRUS (CAM-70 STRAIN) + RUBELLA VIRUS (WISTAR RA 27/3 STRAIN) (? 1000 CCID50 + ? 1000 CCID50)/0.5 ML( DOSE)BIOLOGICAL E. LIMITED , PLOT NO. 1, BIOTECH PARK, PHASE-II, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL-MALKAJGIRI DISTRICT, TELENGANA STATE, 500078 - INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X5.0 DOSE VIAL + 1*50*2.5ML AMPOULE OF NACL, 1.0X50.0X10.0 DOSE VIAL + 1*50*5ML AMPOULE OF NACL09/09/2022
483NDA/MAL/HDP/10343DAWA LIMITED-SUPER MEDIC LTDKENAZOLEKETOCONAZOLE2%W/WDAWA LIMITED, PLOT NO. 7879/8 BABADOGO ROAD, RUARAKA P. O. BOX 16633-00620 NAIROBI, KENYAKENYATOPICAL EXTERNAL CREAMS 1.0X1.0X20.0 G TUBE09/09/2022
484NDA/MAL/HDP/10349SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDTRIDEM PHARMA UGANDA LIMITEDGLUMACARTEMETHER + LUMEFANTRINE80MG + 480MGGUILIN PHARMACEUTICAL CO LTD ., NO. 43, QULIDIAN ROAD, GUILIN 541004CHINAORAL SOLID ORDINARY TABLETS 1.0X1.0X6.0 TABLET BLISTER,30.0X6.0 TABLET BLISTER09/09/2022
485NDA/MAL/HDP/10351ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDROYALTRIM 160 MG + 800 MGTRIMETHOPRIM + SULFAMETHOXAZOLE160 MG + 800 MGSYNOKEM PHARMACEUTICALS LIMITED-PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) |INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER19/09/2022 00:00
486NDA/MAL/HDP/10352ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDROYALTRIM 80 MG + 400 MGTRIMETHOPRIM + SULFAMETHOXAZOLE80 MG + 400 MGSYNOKEM PHARMACEUTICALS LIMITED-PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) |INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER19/09/2022 00:00
487NDA/MAL/HDP/10355INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDRIVATAS 15RIVAROXABAN15 MGINTAS PHARMACEUTICALS LTD.-PLOT NO. 457, 458, & 191/218P,VILLAGE: MATODA, TAL. SANAND, AHMEDABAD, GUJARAT, 382210 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER03/10/2022
488NDA/MAL/HDP/10358PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDVOLDIC - KDICLOFENAC POTASSIUM50MGPHARMA INTERNATIONAL CO. LTD , AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER09/09/2022
489NDA/MAL/HDP/10360KESAR PHARMASWASTIK PHARMACEUTICAL LTDTERBIQUITETERBINAFINE HYDROCHLORIDE1.0% W/WKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT |INDIA | TOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE19/09/2022 00:00
490NDA/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 1.0X10.0X10.0 TABLET BLISTER19/09/2022
491NDA/MAL/HDP/10365MYLAN LABORATORIES LIMITED-KIMSY MEDS LTDMYLTEGA DTDOLUTEGRAVIR SODIUM10MGMYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH;INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X90.0 TABLET BOTTLE09/09/2022
492NDA/MAL/HDP/10367MICRO LABS LIMITEDLABOREX UGANDA LIMITEDSUVITRA €“ 750LEVETIRACETAM750MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER19/09/2022
493NDA/MAL/HDP/10369AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDSITAPRIL 50SITAGLIPTIN PHOSPHATE MONOHYDRATE50MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
494NDA/MAL/HDP/10370AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDSITAPRIL 100SITAGLIPTIN PHOSPHATE MONOHYDRATE100MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
495NDA/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 WFI21/09/2022
496NDA/MAL/HDP/10378CENTURION LABORATORIES PVT. LTD. BIOGEN PHARMA LIMITEDESOMIZAPESOMEPRAZOLE MAGNESIUM TRIHYDRATE40MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER19/09/2022
497NDA/MAL/HDP/10382PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDPINN-TRYPTILLINAMITRIPTYLINE HYDROCHLORIDE25MGPINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER09/09/2022
498NDA/MAL/HDP/10390AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDARTEFAN DT 40/240ARTEMETHER + LUMEFANTRINE40MG + 240MGAJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X6.0 TABLET BLISTER09/09/2022
499NDA/MAL/HDP/10391SANDOZ GMBH .SURGIPHARM (U) LIMITEDHYDROXYUREA 100MGHYDROXYCARBAMIDE100MGHAUPT PHARMA AMAREG GMBH-DONAUSTAUFER STRASSE 378, 93055 REGENSBURG | SIEGFRIED BARBERA, S.L.-RONDA SANTA MARIA 158, 08210 BARBERA DEL VALLES, BARCELONA, SPAIN. | GERMANY| SPAINORAL 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 BOTTLE01/07/2011
500NDA/MAL/HDP/10392SANDOZ GMBH .SURGIPHARM (U) LIMITEDHYDROXYUREA 1000MGHYDROXYCARBAMIDE1000MGHAUPT PHARMA AMAREG GMBH-DONAUSTAUFER STRASSE 378, 93055 REGENSBURG |SIEGFRIED BARBERA, S.L.-RONDA SANTA MARIA 158, 08210 BARBERA DEL VALLES, BARCELONA, SPAIN. | GERMANY| SPAINORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE01/07/1997
501NDA/MAL/HDP/1041SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDREPOITINRECOMBINANT HUMAN ERYTHROPOIETIN4000 I.U/1MLSERUM INSTITUTE OF INDIA LTD, 212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0X1.0 ML PRE- FILLED SYRINGE,1.0X1.0X1.0 ML VIAL01/07/2013
502NDA/MAL/HDP/10418AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRA CT 100SILDENAFIL CITRATE100 MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X4.0 TABLET BLISTER08/02/2023
503NDA/MAL/HDP/10419AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDSITAPRIL M 50/1000SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE50 MG + 1000 MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
504NDA/MAL/HDP/1042ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDARISTO TELVAS-H 80/12.5 TELMISARTAN +HYDROCHLOROTHIAZIDE80MG +12.5 MGARISTO PHARMACEUTICALS PVT. LIMITED, PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET STRIP01/07/2013
505NDA/MAL/HDP/10420AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDSITAPRIL M 50/500SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE50 MG + 500 MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
506NDA/MAL/HDP/10421MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDMIOPOLOL ER 50METOPROLOL SUCCINATE50MGINVENTIA HEALTHCARE PVT LTD , F1-F1/1 ADDITIONAL MIDC AMBERNATH (E) DIST. THANEINDIAORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
507NDA/MAL/HDP/10422MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDMIOPOLOL ER 25METOPROLOL SUCCINATE25MGINVENTIA HEALTHCARE PVT LTD , F1-F1/1 ADDITIONAL MIDC AMBERNATH (E) DIST. THANEINDIAORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
508NDA/MAL/HDP/10423S KANT HEALTHCARE LTD -ABACUS PHARMA (AFRICA) LIMITEDMALAKANT DISPERSIBLE JUNIORSULFADOXINE + PYRIMETHAMINE250MG + 12.5MGS KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA.INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X25.0X3.0 TABLET BLISTER10/02/2023
509NDA/MAL/HDP/10424S KANT HEALTHCARE LTD -ABACUS PHARMA (AFRICA) LIMITEDMALAKANT DISPERSIBLESULFADOXINE + PYRIMETHAMINE500MG + 25MGS KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA.INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X25.0X3.0 TABLET BLISTER10/02/2023
510NDA/MAL/HDP/10427AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCELMAC 400CELECOXIB40 MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER08/02/2023
511NDA/MAL/HDP/10428DENK PHARMA GMBH & COBENLE CONSULT LIMITEDAMOXI-DENK 1000AMOXICILLIN TRIHYDRATE1000 MGPENCEF PHARMA GMBH, BREITENBACHSTRABE 13-14, 13509 BERLIN - GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER08/02/2023
512NDA/MAL/HDP/10429DENK PHARMA GMBH & COBENLE CONSULT LIMITEDAMOXI-DENK 500AMOXICILLIN TRIHYDRATE500 MGPENCEF PHARMA GMBH, BREITENBACHSTRABE 13-14, 13509 BERLIN - GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER08/02/2023
513NDA/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: 403722INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X120.0 CAPSULE CONTAINER08/02/2023
514NDA/MAL/HDP/10432GUFIC BIOSCIENCES LTDEUROPA HEALTHCARE (U) LTDVAMOCIN 500VANCOMYCIN HYDROCHLORIDE500MGGUFIC BIOSCIENCES LIMITED (UNIT 2), SURVEY NO. 171, NATIONAL HIGHWAY NO. 8, NEAR GRID, AT & PO: KABILPORE, NAVSARI - 396424, GUJARAT - INDIAINDIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X500.0 MG VIAL10/02/2023
515NDA/MAL/HDP/10433BIOLOGICAL E. LIMITEDGITTOES PHARMACEUTICALS LIMITEDTETANUS ANTITOXIN 1500 IU/ML BPTETANUS ANTITOXIN1500 IU/MLBIOLOGICAL E. LIMITED, 18/1 & 3, AZAMABAD, HYDERABAD, TELANGANAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0X20.0 ML VIAL08/02/2023
516NDA/MAL/HDP/10436YICHANGHUMANWELL PHARMACEUTICAL CO., LTD.KAIYUANTANG (U) LIMITEDPETHIDINE HYDROCHLORIDE INJECTIONPETHIDINE HYDROCHLORIDE50 MG/MLYICHANG HUMANWELL PHARMACEUTICAL COMPANY LIMITED-NO. 19, DALIAN ROAD, YICHANG DEVELOPING ZONE, YICHANG, HUBEI, CHINA | CHINA | PARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE10/02/2023
517NDA/MAL/HDP/1044UNITED PHARMACEUTICAL MANUFACTURING CO. LTDUNITED HEALTHCARE DISTRIBUTORS LTDANGINET 80MGVALSARTAN80MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
518NDA/MAL/HDP/10446BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDZITHROPLUS 500AZITHROMYCIN DIHYDRATE500 MGBIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT |INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0X1.0X3.0 TABLET BLISTER10/02/2023 00:00
519NDA/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 - INDONESIAINDONESIAPARENTERAL ORDINARY AMPOULES 1.0X2.0X1.0X5.0X2.0 ML AMPOULE08/02/2023
520NDA/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 - INDONESIAINDONESIATOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE10/02/2023
521NDA/MAL/HDP/10449PT SANBE FARMAMEDVIN PHARMA LIMITEDPOLIDEMISINNEOMYCIN SULFATE + POLIMYXYN B SULFATE + DEXAMETHASONE(3.5 MG + 6000 IU + 1 MG)MLPT. SANBE FARMA STERILE PREPARATION PLANT - (UNIT 3), JALAN INDUSTRI CIMAREME NO. 8 DESA CIMAREME, KECAMATAN PADALARANG, KABUPATEN BANDUNG BARAT 40553 - INDONESIAINDONESIAOPHTHALMIC SUSPENSIONS 1.0X1.0X5.0 ML BOTTLE08/02/2023
522NDA/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 - INDONESIAINDONESIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP08/02/2023
523NDA/MAL/HDP/10451GUANGZHOU WONDFO BIOTECH CO. LTDMETRO PHARMACEUTICALS LIMITEDWAXFREESODIUM BICARBONATE5%W/VLINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIANASAL TOPICAL LIQUIDS 1.0X1.0X10.0 ML BOTTLE08/02/2023
524NDA/MAL/HDP/10460PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDAERIALLERG 5MGDESLORATIDINE5 MGPHARMA INTERNATIONAL CO. LTD , AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
525NDA/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, AMAANJORDANORAL LIQUID ORDINARY SYRUPS 1.0X1.0X125.0 ML BOTTLE08/02/2023
526NDA/MAL/HDP/10463FAES FARMA S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDISFORMETHOCARBAMOL500 MGFAES FARMA SA, MAXIMO AGUIRRE 14. 48940 LEIOA €“ SPAINSPAINORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER08/02/2023
527NDA/MAL/HDP/10464JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN 4 FLU TABLETSDIPHENHYDRAMINE + PARACETAMOL + PSEUDOEPHEDRINE12.5MG + 500MG + 22.5MGJOHNSON & JOHNSON (PTY) LTD, 241 MAIN ROAD, RETREAT, 7945, CAPE TOWN| SPECGX LLC, 100 LOUIS LATZER DRIVE, GREENVILLE, ILLINOIS, 62246 - UNITED STATES OF AMERICAUNITED STATESORAL SOLID ORDINARY TABLETS 1.0X2.0X12.0 TABLET BLISTER08/02/2023
528NDA/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 BLISTER10/02/2023
529NDA/MAL/HDP/10468ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDCORTIRIV-100HYDROCORTISONE SODIUM SUCCINATE100 MG/VIALEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X100.0 MG VIAL,1.0X50.0X100.0 MG VIAL08/02/2023
530NDA/MAL/HDP/1047UNITED PHARMACEUTICAL MANUFACTURING CO. LTDUNITED HEALTHCARE DISTRIBUTORS LTDEXOFEN 180MGFEXOFENADINE 180MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X15.0 TABLET BLISTER01/07/2013
531NDA/MAL/HDP/10471ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDCIPROSCOT-500CIPROFLOXACIN HYDROCHLORIDE500 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 BLISTER,1.0X10.0X10.0 TABLET BLISTER10/02/2023
532NDA/MAL/HDP/10477CENTURION LABORATORIES PVT. LTD. BIOGEN PHARMA LIMITEDPENACAMPIROXICAM20 MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER10/02/2023
533NDA/MAL/HDP/10483NVS KENYA LTD SURGIPHARM (U) LIMITEDPATIZRARANIBIZUMAB10 MG/MLNOVARTIS PHARMA STEIN AG STERILE OPERATIONS SOLID OPERATIONS, NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE, 4332 STEIN - SWITZERLANDSWITZERLANDPARENTERAL ORDINARY VIALS 1.0X1.0X0.23 ML VIAL08/02/2023
534NDA/MAL/HDP/1049GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE BETAMETHASONE VALERATE0.1%W/WAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE01/07/2013
535NDA/MAL/HDP/10491GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAPRETUDE 30 MGCABOTEGRAVIR30 MGGLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS), PRIORY STREET, WARE, SG12 ODJ| GLAXO WELLCOME S.A, AVENIDA EXTREMADURA 3, 09400 ARANDA DE DUERO - SPAINUNITED KINGDOM, SPAINORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET CONTAINER10/02/2023
536NDA/MAL/HDP/10493CENTURION LABORATORIES PVT. LTD. BIOGEN PHARMA LIMITEDROUNOXTRAMADOL HYDROCHLORIDE50 MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER10/02/2023
537NDA/MAL/HDP/10496UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDIRIS SYRUPDESLORATADINE0.5 MG/MLUNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY, AL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDANJORDANORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE08/02/2023
538NDA/MAL/HDP/1050INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDAMTAS-10AMLODIPINE 10MG INTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND)| INTAS PHARMACEUTICALS LTD, PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER01/07/2013
539NDA/MAL/HDP/10505ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDOPTOR EYE DROPSKETOROLAC TROMETHAMINE0.5%W/VABACUS PARENTERAL DRUGS LIMITED, PLOT 114, BLOCK 191, KINGAUGANDAOPHTHALMIC DROPS 1.0X1.0X10.0 ML BOTTLE08/02/2023
540NDA/MAL/HDP/10513MS PHARMA JORDAN CO.LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEXITINE 0.5MG/5MLFLUMAZENIL0.5MG/5MLMS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE.JORDANPARENTERAL ORDINARY VIALS 1.0X5.0X5.0 ML VIAL10/02/2023
541NDA/MAL/HDP/10519PT SANBE FARMAMEDVIN PHARMA LIMITEDPLASMINEXTRANEXAMIC ACID500MGPT SANBE FARMA UNIT 1, JALAN INDUSTRI I NO. 9 RT. 01 RW.08, KELURAHAN UTAMA, KECAMATAN CIMAHI SELATAN, KOTA CIMAHI 40553 - INDONESIAINDONESIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP08/02/2023
542NDA/MAL/HDP/1052GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMICLOGEN MICONAZOLE NITRATE+CLOBETASOLE PROPIONATE+GENTAMICIN SULPHATE2.0%W/W+0.05%W/W+0.1W/WAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2013
543NDA/MAL/HDP/10523 SUN PHARMACEUTICAL INDUSTRIES LIMITED -STAR PHARMACEUTICALS LTDSYNRIAM DTARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE37.5 MG + 187.5 MGSUN PHARMACEUTICAL IND. LTD, PLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X3.0 TABLET BLISTER08/02/2023
544NDA/MAL/HDP/10528THE SEARLE COMPANY LIMITEDSURGIPHARM (U) LIMITEDEZIUM 20 MGESOMEPRAZOLE MAGNESIUM TRIHYDRATE20MGTHE SEARLE COMPANY LIMITED, F-319, S.I.T.E KARACHI 75530 - PAKISTANPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X2.0X7.0 CAPSULE BLISTER10/02/2023
545NDA/MAL/HDP/10529THE SEARLE COMPANY LIMITEDSURGIPHARM (U) LIMITEDEZIUM 40 MGESOMEPRAZOLE MAGNESIUM TRIHYDRATE40MGTHE SEARLE COMPANY LIMITED, F-319, S.I.T.E KARACHI 75530 - PAKISTANPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X2.0X7.0 CAPSULE BLISTER10/02/2023
546NDA/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)INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
547NDA/MAL/HDP/10530ZOTA HEALTHCARE LTDHARLEYS UGANDA LIMITEDCOXZOTA 120ETORICOXIB120MGZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
548NDA/MAL/HDP/10531GLAXOSMITHKLINE LIMITED-UNITED HEALTHCARE DISTRIBUTORS LTDENO CALCIUM ANTACID TABLETSCALCIUM CARBONATE500MGGLAXOSMITHKLINE LIMITED, LIKONI ROAD, INDUSTRIAL AREA, P.O. BOX 78392-00507, VIWANDANI, NAIROBI| GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC, 320 SOUTH BROADWAY ST. LOUIS, MISSOURI, 63102 - UNITED STATES OF AMERICAKENYA| UNITED STATESORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER08/02/2023
549NDA/MAL/HDP/10532ALKEM LABORATORIES LTDABACUS PHARMA (AFRICA) LIMITEDTAXIM-OCEFIXIME TRIHYDRATE400MGEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X5.0 CAPSULE BLISTER08/02/2023
550NDA/MAL/HDP/10539ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDZOTAMET-850METFORMIN HYDROCHLORIDE850MGZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
551NDA/MAL/HDP/1054GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-250AZITHROMYCIN250MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X6.0 CAPSULE BLISTER01/07/2011
552NDA/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), INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE10/02/2023
553NDA/MAL/HDP/10543ADWIAWIDE SPECTRUM ENTERPRISES (U) LIMITEDADWIFLAMDICLOFENAC POTASSIUM75MGSOUTH EGYPT DRUG INDUSTRIES COMPANY (SEDICO), FIRST INDUSTRIAL ZONE, 6TH OF OCTOBER CITY - EGYPTEGYPTRECTAL SYSTEMIC SUPPOSITORIES 1.0X1.0X5.0 SUPPOSITORY STRIP10/02/2023
554NDA/MAL/HDP/10545BROOKES PHARMA (PRIVATE) LIMITEDHARLEYS UGANDA LIMITEDBRAMOLPARACETAMOL10MG/MLBROOKES PHARMA (PRIVATE) LIMITED, 58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900PAKISTANPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML VIAL08/02/2023
555NDA/MAL/HDP/10546BROOKES PHARMA (PRIVATE) LIMITEDHARLEYS UGANDA LIMITEDOXOFERINTETRACHLORODECAOXIDE138.0 X 10^6 PMOL/100MLBROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 |PAKISTAN | TOPICAL EXTERNAL LIQUIDS 1.0X1.0X50.0 ML BOTTLE10/02/2023 00:00
556NDA/MAL/HDP/10547PROFARMA SH.AJOINT MEDICAL STORE (UPMB - UCMB)HALOPERIDOL SOLUTION FOR INJECTION 5MG/MLHALOPERIDOL5MG/MLPROFARMA SH.A-MYSLYM KETA,TIRANA | ALBANIA | PARENTERAL ORDINARY VIALS 1.0X2.0X5.0X1.0 ML VIAL10/02/2023
557NDA/MAL/HDP/10556KESAR PHARMASWASTIK PHARMACEUTICAL LTDPIADINPOVIDONE IODINE5.0 W/WKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT |INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X10.0 G TUBE10/02/2023 00:00
558NDA/MAL/HDP/10557BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDLOFNAC-50DICLOFENAC SODIUM50MGBLISS GVS PHARMA LIMITED, 10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER08/02/2023
559NDA/MAL/HDP/1056GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE-N OINTMENT BETAMETHASONE + NEOMYCIN0.1%W/W + 0.5% W/WAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL OINTMENTS 1.0X1.0X15.0 G TUBE01/07/2013
560NDA/MAL/HDP/10564MYLAN LABORATORIES LIMITED-KIMSY MEDS LTDISONIAZID/PYRIDOXINE HYDROCHLORIDE/SULFAMETH OXAZOLE TRIMETHOPRIM TABLETS 300 MG/25 MG/800 MG/160 MGISONIAZID + PYRIDOXINE HYDROCHLORIDE + SULFAMETHOXAZOLE + TRIMETHOPRIM300 MG + 25 MG + 800 MG + 160 MGMYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH;INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BOTTLE10/02/2023
561NDA/MAL/HDP/10567AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDCELMAC 200CELECOXIB200MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER08/02/2023
562NDA/MAL/HDP/10568AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAMADAY PL 5/4AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE5 MG + 4 MGAJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
563NDA/MAL/HDP/10569AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAMADAY PL 5/8AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE5MG + 8MGAJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
564NDA/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		INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2013
565NDA/MAL/HDP/10570AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAMADAY PL 10/4AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE10 MG + 4 MGAJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
566NDA/MAL/HDP/10571AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAMADAY PL 10/8AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE10MG + 8MGAJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
567NDA/MAL/HDP/10572MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDNAT-B FORTETHIAMINE MONONITRATE (VITAMIN B1) + PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) + METHYLCOBALAMIN (VITAMIN B12) + FOLIC ACID + D-ALPHA-TOCOPHEROL ACETATE + VITAMIN A + VITAMIN D3 + COPPER SULPHATE ANHYDROUS + CHROMIUM PICOLINATE + ZINC AMINO ACID CHELATE100 MG + 200 MG + 500 MCG + 200 MCG + 200 IU + 5000 IU + 400 IU + 1.0 MG + 0.20 MG + 15.0 MGMEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILANDTHAILANDORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER08/02/2023
568NDA/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.INDIATOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE08/02/2023
569NDA/MAL/HDP/10579 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDBENZYL BENZOATE APPLICATION BPBENZYL BENZOATE25%W/VRENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALAUGANDATOPICAL EXTERNAL EMULSIONS 1.0X100.0 ML BOTTLE08/02/2023
570NDA/MAL/HDP/10589PSYCHOTROPICS INDIA LIMITED.ABACUS PHARMA (AFRICA) LIMITEDPILECA-EZATORVASTATIN + EZETIMIBE10 MG + 10 MGPSYCHOTROPICS INDIA LTD, PLOT NO. 46 & 49, SECTOR-6A,IIE, SIDCUL,HARIDWAR -249403( UTTARAKHARD)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER06/03/2023
571NDA/MAL/HDP/10590MYLAN LABORATORIES LIMITED-KIMSY MEDS LTDULCEREST 20ESOMEPRAZOLE MAGNESIUM20MGMYLAN LABORATORIES LTD ., F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X28.0 TABLET BOTTLE06/03/2023
572NDA/MAL/HDP/10591MYLAN LABORATORIES LIMITED-KIMSY MEDS LTDULCEREST 40ESOMEPRAZOLE MAGNESIUM40MGMYLAN LABORATORIES LTD ., F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X28.0 TABLET BOTTLE06/03/2023
573NDA/MAL/HDP/10592ATCO LABORATORIES LIMITEDHARLEYS UGANDA LIMITEDASCARD-75ASPIRIN75MGATCO LABORATORIES LIMITED-B-18, S.I.T.E, KARACHI - 74700 |PAKISTAN | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER06/03/2023 00:00
574NDA/MAL/HDP/10597MEDISEL(K) LTDSUPER MEDIC LTDGABANERVEGABAPENTIN + METHYLCOBALAMIN300MG + 500MCGCORONA REMEDIES PVT. LTD, VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER15/02/2023
575NDA/MAL/HDP/10600MEDISEL(K) LTDAIVEEN (U) LIMITEDOSTEOCERINGLUCOSAMINE SULPHATE POTASSIUM CHLORIDE + METHL SULPHONYL METHANE (MSM) + DIACEREIN750MG + 250MG + 50MGCORONA REMEDIES PVT. LTD, VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER15/02/2023
576NDA/MAL/HDP/10604ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDPIPERATAZ 4.5PIPERACILLIN + TAZOBACTAM4 G + 0.5 GUNI MEDICOLABS-UNI MEDICOLABS, PLOT NO. 21-22, PHARMACITY, SELAQUI, DEHRADUN - 248011 | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0X4.5 G VIAL06/03/2023
577NDA/MAL/HDP/10605PSYCHOTROPICS INDIA LIMITED.ABACUS PHARMA (AFRICA) LIMITEDHALOPACHALOPERIDOL5MGPSYCHOTROPICS INDIA LTD, PLOT NO. 46 & 49, SECTOR-6A,IIE, SIDCUL,HARIDWAR -249403( UTTARAKHARD)INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER21/03/2023
578NDA/MAL/HDP/10606MEDISEL(K) LTDAIVEEN (U) LIMITEDEMADON SYRUPONDANSETRON HYDROCHLORIDE2MG/5MLCORONA REMEDIES PVT. LTD, VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223INDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X30.0 ML BOTTLE15/02/2023
579NDA/MAL/HDP/10607CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.DOLACKETOROLAC TROMETHAMINE10 MGCADILA PHARMACEUTICALS LTD, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDABAD, GUJARAT STATE, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET STRIP15/02/2023
580NDA/MAL/HDP/10609ORANEAIVEEN (U) LIMITEDOCUDORDORZOLAMIDE HYDROCHLORIDE2%W/VFDC LIMITED-WALUJ., PLOT B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 (DIST AURANGABAD)INDIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE15/02/2023
581NDA/MAL/HDP/1061SHOSAAN ASIC PACIFICRENE PHARMACY LTDBISACODYL TABLETSBISACODYL5MGNEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATEINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2010
582NDA/MAL/HDP/10611PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDNEWSTAR 160/10 MGVALSARTAN + AMLODIPINE BESYLATE160 MG + 10 MGPHARMA INTERNATIONAL CO. LTD -AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAAN |JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER06/03/2023 00:00
583NDA/MAL/HDP/10612PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDNEWSTAR 160/5 MGVALSARTAN + AMLODIPINE BESYLATE160 MG + 5 MGPHARMA INTERNATIONAL CO. LTD -AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAAN |JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER06/03/2023 00:00
584NDA/MAL/HDP/10613ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDSYNER-CEF 500CEFUROXIME AXETIL500MGM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED, HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER06/03/2023
585NDA/MAL/HDP/10614S KANT HEALTHCARE LTD -ABACUS PHARMA (AFRICA) LIMITEDAVIRAXACICLOVIR5% W/WS KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA.INDIATOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE06/03/2023
586NDA/MAL/HDP/10615LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLEVOZIN 5LEVOCETIRIZINE DIHYDROCHLORIDE5MGLINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
587NDA/MAL/HDP/10616COSMOS LTD.ASTRA PHARMA (U) LIMITEDGLYSIT 5DAPAGLIFLOZIN5MGCOSMOS LTD.., RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER15/02/2023
588NDA/MAL/HDP/10617COSMOS LTD.ASTRA PHARMA (U) LIMITEDGLYSIT 10DAPAGLIFLOZIN10MGCOSMOS LTD.., RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER15/02/2023
589NDA/MAL/HDP/10618BHARAT SERUMS & VACCINES LTD.ABACUS PHARMA (AFRICA) LIMITEDFOLIGRAF 150 I.URECOMBINANT - HUMAN FOLLICLE STIMULATING HORMONE (R-HFSH)150 I.U/1ML BHARAT SERUM AND VACCINES LIMITED, PLOT NO. K-27 ADDITIONAL M.I.D.C INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0X1.0 ML PRE- FILLED SYRINGE15/02/2023
590NDA/MAL/HDP/10619?LKO ?LAÇ SANAYI VE TICARET A. ?. CORE ACCESS LIMITEDDEXIRENDEXKETOPROFEN TROMETAMOL50MG/2MLIDOL LLAC DOLUM A.S-DAVUTPASA CADDESI. CEBE ALI BEY SOK. NO. 20 34010/ DAVUTPASA - TOPKAPI / ISTANBUL | TURKEY | PARENTERAL ORDINARY AMPOULES 1.0X1.0X6.0X2.0 ML AMPOULE21/03/2023
591NDA/MAL/HDP/1062VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDVANCONEX-CPVANCOMYCIN500MGVENUS REMEDIES LIMITED, UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP
PHASE I BHATOLI BADDI (HP) 173205
INDIA		INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON01/07/2013
592NDA/MAL/HDP/10621RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPENIRENPHENOXYMETHYLPENICILLIN POTASSIUM250MGRENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
593NDA/MAL/HDP/10622CENTURION LABORATORIES PVT. LTD. BIOGEN PHARMA LIMITEDPANTOPRAM 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40 MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER21/03/2023
594NDA/MAL/HDP/10623RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDSTERIRENCHLORHEXIDINE GLUCONATE5% W/VRENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALAUGANDATOPICAL EXTERNAL LIQUIDS 1.0X5.0 L CONTAINER15/02/2023
595NDA/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 - INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
596NDA/MAL/HDP/10630INNOVA CAPTAB LTD.TATA UGANDA LIMITEDINFIXIME 400CEFIXIME TRIHYDRATE400MGINNOVA CAPTAB PVT. LTD-1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) |INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER21/03/2023 00:00
597NDA/MAL/HDP/10636UNICHEM LABORATORIES LIMITEDˆŠEUROPA HEALTHCARE (U) LTDUNIPROEX ER 250DIVALPROEX SODIUM250MGUNICHEM LABORATORIES LTD-PLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 |INDIA | ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER06/03/2023 00:00
598NDA/MAL/HDP/10638ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDCLOTRIMAZOLE, BETAMETHASONE DIPROPIONATE, GENTAMICIN SULPHATE CREAMCLOTRIMAZOLE + BETAMETHASONE DIPROPIONATE + GENTAMICIN SULPHATE(10 MG + 0.5 MG + 1 MG)/GCIRON DRUGS AND PHARMACEUTICALS PVT LTD ., N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, MAHARASHTRA STATEINDIATOPICAL EXTERNAL CREAMS 1.0X1.0X20.0 G TUBE06/03/2023
599NDA/MAL/HDP/10639ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDCIROVIRACICLOVIR5%W/WCIRON DRUGS AND PHARMACEUTICALS PVT LTD .-N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, MAHARASHTRA STATE |INDIA | TOPICAL EXTERNAL CREAMS 1.0X1.0X5.0 G TUBE,1.0X1.0X10.0 G TUBE06/03/2023 00:00
600NDA/MAL/HDP/10640FAES FARMA S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDISTEMMETHOCARBAMOL + PARACETAMOL380 MG + 300 MGFAES FARMA SA, MAXIMO AGUIRRE 14. 48940 LEIOA €“ SPAINSPAINORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER06/03/2023
601NDA/MAL/HDP/10645MS PHARMA JORDAN CO.LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDVINKAMINEVANCOMYCIN HYDROCHLORIDE500MGMS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE.JORDANPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X1.0X500.0 MG VIAL06/03/2023
602NDA/MAL/HDP/10646TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ENZYSTAL PPANCREAS POWDEREQUIVALENT TO AMYLASE ACTIVITY 4200 PH. EUR UNITS, LIPASE ACTIVITY 3500 PH. EUR UNITS AND PROTEASE ACTIVITY 250 PH. EUR UNITSTORRENT PHARMACEUTICALS LTD , VILLAGE: BHUD & MAKHNU MAJRA, TEHSIL: BADDI €“ 173205, DIST: SOLAN, HIMACHAL PRADESH, INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER06/03/2023
603NDA/MAL/HDP/1065BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM-5DIAZEPAM5MGBLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES 1.0X5.0 SUPPOSITORY BLISTER01/07/2007
604NDA/MAL/HDP/10650GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMEROPENEM FOR INJECTION USPMEROPENEM TRIHYDRATE1GCSPC OUYI PHARMACEUTICAL CO. LTD., WORKSHOPS 112,113 AND 117 PLOT NO. 88 YANGZI ROAD,ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINACHINAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL06/03/2023
605NDA/MAL/HDP/10651PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBROZELINAMBROXOL HYDROCHLORIDE + SALBUTAMOL + GUAIPHENESIN + MENTHOL(30 MG + 2 MG + 50 MG + 1 MG)/5 MLTHE MADRAS PHARMACEUTICALS.., NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096INDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE06/03/2023
606NDA/MAL/HDP/10652ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDZ-OFLOX 200OFLOXACIN200MGZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
607NDA/MAL/HDP/10653ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDCOXZOTA-60ETORICOXIB60MGZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
608NDA/MAL/HDP/10655HETERO LABS LTD AIVEEN (U) LIMITEDTENOFOVIR ALAFENAMIDE TABLETSTENOFOVIR ALAFENAMIDE HEMIFUMARATE25MGHETERO LABS LIMITED (UNIT V), SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE06/03/2023
609NDA/MAL/HDP/10660ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDAZITOZ-250AZITHROMYCIN DIHYDRATE250MGZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER15/02/2023
610NDA/MAL/HDP/10661ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDLIVOTA-750LEVOFLOXACIN HEMIHYDRATE750MGZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER15/02/2023
611NDA/MAL/HDP/10662ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDTOMOZAMOSAPRIDE CITRATE DIHYDRATE5MGZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
612NDA/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 AURANGABADINDIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE15/02/2023
613NDA/MAL/HDP/10666LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDVANCOLIN-500VANCOMYCIN HYDROCHLORIDE500 MGLINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X500.0 MG VIAL15/02/2023
614NDA/MAL/HDP/10668LUPIN LIMITEDAIVEEN (U) LIMITEDDOLUTEGRAVIR SODIUM/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMERATE 50MG/300MG/300MGDOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE50 MG + 300 MG + 300 MGLUPIN LIMITED NAGPUR, PLOT NO. 6A, SECTOR 17, SPECIAL ECONOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X60.0 TABLET CONTAINER15/02/2023
615NDA/MAL/HDP/1067MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDIBUPARAIBUPROFEN+PARACETAMOL200MG+ 250MG/10MLTORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2010
616NDA/MAL/HDP/10672OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDNORSALINE-DSODIUM CHLORIDE + ANHYDROUS GLUCOSE0.9%W/V & 5%W/VOTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED-SURVEY NO. 199 TO 201 & 208 TO 210, MF01 AND MF02 VILLAGE- VASNA CHACHARWADI, TAL. SANAND DISTRICT. AHMEDABAD-382 213 |INDIA | PARENTERAL ORDINARY INFUSION BAGS 1.0X1.0X500.0 ML BAG21/03/2023 00:00
617NDA/MAL/HDP/10675THE SEARLE COMPANY LIMITEDSURGIPHARM (U) LIMITEDJENTIN 50SITAGLIPTIN PHOSPHATE MONOHYDRATE50 MGTHE SEARLE COMPANY LIMITED, F-319, S.I.T.E KARACHI 75530 - PAKISTANPAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER21/03/2023
618NDA/MAL/HDP/10676THE SEARLE COMPANY LIMITEDSURGIPHARM (U) LIMITEDJENTIN 100SITAGLIPTIN PHOSPHATE MONOHYDRATE100 MGTHE SEARLE COMPANY LIMITED, F-319, S.I.T.E KARACHI 75530 - PAKISTANPAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER21/03/2023
619NDA/MAL/HDP/10678KESAR PHARMAABACUS PHARMA (AFRICA) LIMITEDARTELUMARTEMETHER + LUMEFANTRINE20 MG + 120 MGKESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X24.0 TABLET BLISTER21/03/2023
620NDA/MAL/HDP/10679ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDPG-75PREGABALIN75 MGZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARATINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X2.0X14.0 CAPSULE BLISTER15/02/2023
621NDA/MAL/HDP/10686HETERO LABS LTD AIVEEN (U) LIMITEDCELOFEN 200CELECOXIB200MGHETERO LABS LIMITED (UNIT V)-SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER06/03/2023
622NDA/MAL/HDP/10688MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDUROKADUTASTERIDE0.5 MGMEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILANDTHAILANDORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER15/02/2023
623NDA/MAL/HDP/10689ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDLOSARZED-100LOSARTAN POTASSIUM100 MGZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
624NDA/MAL/HDP/1069CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDK-ONE INJECTIONPHYTOMENADIONE10MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD, N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X1.0 ML AMPOULE01/07/2014
625NDA/MAL/HDP/10694MYLAN LABORATORIES LIMITED-KIMSY MEDS LTDOTYCULF 500 MGFLUCYTOSINE500MGMYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH;INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X100.0 TABLET BOTTLE06/03/2023
626NDA/MAL/HDP/10697BHARAT SERUMS & VACCINES LTD.ABACUS PHARMA (AFRICA) LIMITEDASPORELIXCETRORELIX ACETATE0.25MGBHARAT SERUM AND VACCINES LIMITED, PLOT NO. K-27 ADDITIONAL M.I.D.C INDIAINDIAPARENTERAL ORDINARY I V VIALS 1.0X0.25 MG VIAL + 1*1ML GLASS AMPOULE OF WFI15/02/2023
627NDA/MAL/HDP/10704PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDEMEFILM-4ONDANSETRON HYDROCHLORIDE4 MGSHILPA THERAPEUTICS PVT. LIMITED, PLOT NO. 118, PHASE-III, IDA, CHERLAPALLY, MEDCHAL-MALKAJGIRI DISTRICT, HYDERABAD - 500016, TELANGANA, INDIAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X5.0 SACHET CARTON21/03/2023
628NDA/MAL/HDP/10710CADILA HEALTHCARE LIMITED;ABACUS PHARMA (AFRICA) LIMITEDOXALGIN GELDICLOFENAC DIETHYLAMINE+ METHYL SALICYLATE + VIRGIN LINSEED OIL + CAPSAICIN + RACEMENTHOL1.0%W/W + 10.0%W/W + 3.0%W/W + 0.05%W/W + 5.0%W/WEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X1.0X30.0 G TUBE15/02/2023
629NDA/MAL/HDP/10715AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDVILDARIL M 50/500VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 500MGAJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
630NDA/MAL/HDP/10716AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDVILDARIL M 50/850VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 850 MGAJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
631NDA/MAL/HDP/10717AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDVILDARIL M 50/1000VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 1000 MGAJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
632NDA/MAL/HDP/10719HETERO LABS LTD AIVEEN (U) LIMITEDGOAB 5SOLIFENACIN SUCCINATE5 MGM/S. ANNORA PHARMA PRIVATE LIMITED-SY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE – 502313, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER06/03/2023
633NDA/MAL/HDP/1072UNITED PHARMACEUTICAL MANUFACTURING CO. LTDUNITED HEALTHCARE DISTRIBUTORS LTDCO-ANGINET 80/12.5MGVALSARTAN + HYDROCHLOROTHIAZIDE 80MG + 12.5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD ., 57 UBAYBIN MUAATH STREET AL RAGEEM-SAHAB, AMMAN, JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET STRIP01/07/2013
634NDA/MAL/HDP/10720HETERO LABS LTD AIVEEN (U) LIMITEDGOAB 10SOLIFENACIN SUCCINATE10MGM/S. ANNORA PHARMA PRIVATE LIMITED-SY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE – 502313, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER06/03/2023
635NDA/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 - EGYPTEGYPTPARENTERAL ORDINARY S C VIALS 1.0X1.0X10.0 ML VIAL15/02/2023
636NDA/MAL/HDP/10725AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDBESICOR 2.5BISOPROLOL FUMARATE2.5MGAJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
637NDA/MAL/HDP/10726AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDBESICOR 5BISOPROLOL FUMARATE5MGAJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
638NDA/MAL/HDP/10727AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDBESICOR 10BISOPROLOL FUMARATE10MGAJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
639NDA/MAL/HDP/10728LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDRAPI-COOLCHOLINE SALICYLATE + LIDOCAINE HYDROCHLORIDE8.70% W/W + 2.00% W/WLINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAORAL TOPICAL GELS AND SOLS 1.0X10.0 G TUBE15/02/2023
640NDA/MAL/HDP/10729LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBRISCORILSALBUTAMOL SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN(1MG + 2MG + 50MG ) PER 5MLLINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE15/02/2023
641NDA/MAL/HDP/10730UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDUNICHLOR 25CHLORTHALIDONE25MGUNICHEM LABORATORIES LIMITED-C€“31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. |INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER06/03/2023 00:00
642NDA/MAL/HDP/10731UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDUNICHLOR 50CHLORTHALIDONE50 MGUNICHEM LABORATORIES LIMITED-C€“31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. |INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER06/03/2023 00:00
643NDA/MAL/HDP/10736UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDUNIPROEX ER 500DIVALPROEX SODIUM500MGUNICHEM LABORATORIES LTD-PLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 |INDIA | ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER (ALU-ALU BLISTER),1.0X3.0X10.0 TABLET BLISTER (ACLAR €“ PVC BLISTER)06/03/2023 00:00
644NDA/MAL/HDP/10737LAURUS LABS LIMITED - BEYOND LOGISTICS LTDABACAVIR 600 MG AND LAMIVUDINE 300 MG FILM COATED TABLETSABACAVIR SULFATE + LAMIVUDINE600MG + 300MGLAURUS LABS LTD (UNIT 2), PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH,INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE,1.0X180.0 TABLET BOTTLE06/03/2023
645NDA/MAL/HDP/10738SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTDTATA UGANDA LIMITEDDOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETSDOLUTEGRAVIR + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE50 MG + 300 MG + 300 MGSHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD, 1479, ZHANGHENG ROAD, CHINA (SHANGHAI) PILOT FREE TRADE ZONE, SHANGHAI 201203 - CHINACHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE, 1.0X1.0X90.0 TABLET BOTTLE06/03/2023
646NDA/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		INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2013
647NDA/MAL/HDP/10742CADILA HEALTHCARE LIMITED €ŒZYDUS TOWER€ - ABACUS PHARMA (AFRICA) LIMITEDVINGLYNVILDAGLIPTIN50 MGEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER21/03/2023
648NDA/MAL/HDP/10743CADILA HEALTHCARE LIMITED €ŒZYDUS TOWER€ - ABACUS PHARMA (AFRICA) LIMITEDVINGLYN M 50/500VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 500 MGEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER21/03/2023
649NDA/MAL/HDP/10747M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDEFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 400 MG/300 MG/300 MGEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE400 MG + 300 MG + 300 MGHETERO LABS LIMITED (UNIT V), SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER,1.0X90.0 TABLET CONTAINER,1.0X180.0 TABLET CONTAINER21/03/2023
650NDA/MAL/HDP/10749LAURUS LABS LIMITED - BEYOND LOGISTICS LTDTENOFOVIR ALAFENAMIDE TABLETS 25 MGTENOFOVIR ALAFENAMIDE FUMARATE25MGLAURUS LABS LTD (UNIT 2), PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH,INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER21/03/2023
651NDA/MAL/HDP/10750LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDRESTOCIN PLUSPARACETAMOL + DEXTROMETHORPHAN HYDROBROMIDE + PHENYLEPHRINE HYDROCHLORIDE + CHORPHENIRAMINE MALEATE500 MG + 15 MG + 10 MG + 2 MGLINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER15/02/2023
652NDA/MAL/HDP/10753LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDHISTALIN 8BETAHISTINE DIHYDROCHLORIDE8 MGLINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
653NDA/MAL/HDP/10754LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDHISTALIN 16BETAHISTINE DIHYDROCHLORIDE16 MGLINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
654NDA/MAL/HDP/1076UNITED PHARMACEUTICAL MANUFACTURING CO. LTDUNITED HEALTHCARE DISTRIBUTORS LTDUNICAST 4MGMONTELUKAST SODIUM4MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
655NDA/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- 140506INDIATOPICAL EXTERNAL OINTMENTS 1.0X1.0X20.0 G TUBE15/02/2023
656NDA/MAL/HDP/10762MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLINEZOLID TABLETS 600 MGLINEZOLID 600 MGMYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH;INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER21/03/2023
657NDA/MAL/HDP/10764 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCLOPIVIDCLOPIDOGREL HYDROGEN SULPHATE75MGHOVID BERHAD,, LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAKMALAYSIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
658NDA/MAL/HDP/10766CACHET PHARMACEUTICALS PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTRAMA-50TRAMADOL HYDROCHLORIDE50MGCACHET PHARMACEUTICAL PVT LTD., VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH-173205INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER15/02/2023
659NDA/MAL/HDP/10768AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEBUNTA 5NEBIVOLOL HYDROCHLORIDE5 MGAJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
660NDA/MAL/HDP/10769RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIREN-500AMOXICILLIN TRIHYDRATE500MGRENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER15/02/2023
661NDA/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 INDIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE15/02/2023
662NDA/MAL/HDP/10777CENTAUR PHARMACEUTICALS PVT. LTD.GITTOES PHARMACEUTICALS LIMITEDGLUCOTIM 0.5%TIMOLOL MALEATE0.5%W/VCENTAUR PHARMACEUTICALS PVT. LTD (PLANT 1), PLOT 3,5B, 2C TIVIM INDUSTRIAL ESTATE, KARASVADA, MAPUSA, GOA 403526 INDIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE19/04/2023
663NDA/MAL/HDP/1078MICRO LABS LTD LABOREX UGANDA LIMITEDLEVOBACT INFUSIONLEVOFLOXACIN HEMIHYDRATE500MGAHLCON PARENTERALS (INDIA) LTD, SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHANINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE01/07/2013
664NDA/MAL/HDP/10788THE SEARLE COMPANY LIMITEDSURGIPHARM (U) LIMITEDDIULACTONE 25 MGSPIRONOLACTONE25MGSEARLE PAKISTAN LIMITED,, F-319, SITE KARACHIPAKISTANORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER26/05/2023
665NDA/MAL/HDP/1079GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOG-QUININE SYRUPQUININE HYDROCHLORIDE100MG/5MLAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2000
666NDA/MAL/HDP/10790THE SEARLE COMPANY LIMITEDSURGIPHARM (U) LIMITEDDIULACTONE 100 MGSPIRONOLACTONE100MGSEARLE PAKISTAN LIMITED,, F-319, SITE KARACHIPAKISTANORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER26/05/2023
667NDA/MAL/HDP/10791THE SEARLE COMPANY LIMITEDSURGIPHARM (U) LIMITEDVAPTOR 20MGROSUVASTATIN20MGSEARLE PAKISTAN LIMITED,, F-319, SITE KARACHIPAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER26/05/2023
668NDA/MAL/HDP/10793THE SEARLE COMPANY LIMITEDSURGIPHARM (U) LIMITEDNUBIN INJECTION 10MG/MLNALBUPHINE HYDROCHLORIDE10MG/1MLSEARLE PAKISTAN LIMITED,, F-319, SITE KARACHIPAKISTANPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE26/05/2023
669NDA/MAL/HDP/10794THE SEARLE COMPANY LIMITEDSURGIPHARM (U) LIMITEDMORCET 10 MGESCITALOPRAM OXALATE10MGSEARLE PAKISTAN LIMITED,, F-319, SITE KARACHIPAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER26/05/2023
670NDA/MAL/HDP/10795PROFARMA SH.AJOINT MEDICAL STORE (UPMB - UCMB)DIAZEPAM 10MG/2MLDIAZEPAM 10MG/2MLPROFARMA SH.A-MYSLYM KETA,TIRANA | ALBANIA | PARENTERAL ORDINARY AMPOULES 1.0X2.0X5.0X2.0 ML AMPOULE25/05/2023
671NDA/MAL/HDP/10797GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDAPREZOAPREMILAST10MG TABLETS CO-PACKED WITH 20MG TABLETS AND 30MG TABLETSGLENMARK PHARMACEUTICALS LIMITED, PLOT NO. 2, PHASE-II, PHARMA ZONE, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR DIST. DHAR, (M.P.) PIN CODE 454775 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0 CARTON CARTON [4*10MG CO-PACKED WITH 4*20MG CO-PACKED WITH 19*30MG TABLETS],1.0X1.0 CARTON CARTON [4*10MG CO-PACKED WITH 4*20MG CO-PACKED WITH 47*30MG TABLETS]25/05/2023
672NDA/MAL/HDP/10798STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDSTEDNAC PLUSACECLOFENAC + PARACETAMOL100 MG + 325 MGSTEDMAN PHARMACEUTICALS PVT LTD , C-4 SIDCO PHARMACEUTICAL COMPLEX ALATHUR THIRUPORUR 603 110 TAMILNADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER25/05/2023
673NDA/MAL/HDP/10799CIPLA LIMITED.ABACUS PHARMA (AFRICA) LIMITEDGEFITINIB 250MG TABLETSGEFITINIB250MGCIPLA LIMITED, GOA (UNIT X)-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147, L-147/1 TO L-147/3, L-138 AND L-147/A, VERNA INDUSTRIAL ESTATE, VERNA, SALCETTE, GOA. PIN: 403722 |INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER26/05/2023 00:00
674NDA/MAL/HDP/1080ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDZOCEF 250 TABLETSCEFUROXIME AXETIL250MG EAST AFRICAN (INDIA) OVERSEAS (PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER, 1.0X1.0X10.0 TABLET BLISTER01/07/2013
675NDA/MAL/HDP/10801MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDPERGOVERIS (900 IU + 450 IU)/1.44MLFOLLITROPIN ALFA + LUTROPIN ALFA(900 IU + 450 IU)/1.44MLMERCK SERONO S.P.A,., VIA DELLE MAGNOLIE 15 (LOC FRANZIONE ZONA IDUSTRIALE) 70026, MODUGNO BAITALYPARENTERAL ORDINARY PRE-FILLED PENS 1.0X1.0X1.44 ML PREFILLED PEN + 14 INJECTION NEEDLES25/05/2023
676NDA/MAL/HDP/10802MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDPERGOVERIS (300 IU + 150 IU)/1.44MLFOLLITROPIN ALFA + LUTROPIN ALFA(300 IU + 150 IU)/1.44MLMERCK SERONO S.P.A,., VIA DELLE MAGNOLIE 15 (LOC FRANZIONE ZONA IDUSTRIALE) 70026, MODUGNO BAITALYPARENTERAL ORDINARY PRE-FILLED PENS 1.0X1.0X1.44 ML PREFILLED PEN + 5 INJECTION NEEDLES25/05/2023
677NDA/MAL/HDP/10803MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDPERGOVERIS (450 IU + 225 IU)/0.72 MLFOLLITROPIN ALFA + LUTROPIN ALFA(450 IU + 225 IU)/0.72MLMERCK SERONO S.P.A,., VIA DELLE MAGNOLIE 15 (LOC FRANZIONE ZONA IDUSTRIALE) 70026, MODUGNO BAITALYPARENTERAL ORDINARY PRE-FILLED PENS 1.0X1.0X0.72 ML PREFILLED PEN25/05/2023
678NDA/MAL/HDP/10804WALLACE PHARMACEUTICALS PVT. LTDSTAR PHARMACEUTICALS LTDCOLIMEX TABLETSDICYCLOVERINE HYDROCHLORIDE + PARACETAMOL20MG + 500MGWALLACE PHARMACEUTICALS PVT LTD, BHATIAN, NALAGARH, DIST. SOLAN HP 174101INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER26/05/2023
679NDA/MAL/HDP/10806ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDLOSARZED-50LOSARTAN POTASSIUM50MGZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER03/05/2023
680NDA/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, GUJARATINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE03/05/2023
681NDA/MAL/HDP/10808ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDROSUNA-10ROSUVASTATIN CALCIUMROSUNA-10ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER03/05/2023
682NDA/MAL/HDP/10812MICRO LABS LTDLABOREX UGANDA LIMITEDURYSOREN-5SOLIFENACIN SUCCINATE5 MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER26/05/2023
683NDA/MAL/HDP/10813MICRO LABS LTD LABOREX UGANDA LIMITEDURYSOREN-10SOLIFENACIN SUCCINATE10 MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER26/05/2023
684NDA/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, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER03/05/2023
685NDA/MAL/HDP/10817M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDCELOFEN 100CELECOXIB100 MGHETERO LABS LIMITED (UNIT III)-VILLAGE KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, PIN CODE: 173205 | HETERO LABS LIMITED (UNIT V)-SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER26/05/2023
686NDA/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, GUJARATINDIAOPHTHALMIC DROPS 1.0X1.0X10.0 ML BOTTLE03/05/2023
687NDA/MAL/HDP/1082DAWA LIMITEDSUPER MEDIC LTDDACOF PAEDIATRICDIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + MENTHOL75MG + 28.5MG + 0.55MGDAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2013
688NDA/MAL/HDP/10820AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDOLOPAT EYE DROPSOLOPATADINE HYDROCHLORIDE0.1%W/VCIRON DRUGS AND PHARMACEUTICALS PVT LTD ., N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, MAHARASHTRA STATEINDIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML CONTAINER25/05/2023
689NDA/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| ITALY|ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER21/11/2019
690NDA/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| ITALY| ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER21/11/2019
691NDA/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| ITALY|ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER21/11/2019
692NDA/MAL/HDP/10831AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDLASTAVIN 80VALSARTAN80 MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER19/06/2023
693NDA/MAL/HDP/10832AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLASTAVIN 160VALSARTAN160MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER06/06/2023
694NDA/MAL/HDP/10833AUROBINDO PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDMOLNAFLUMOLNUPIRAVIR200MGAUROBINDO PHARMA LIMITED UNIT 3, PLOT NO. 313, 314, BACHUPALLY, RR DIST. 500090 INDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X40.0 CAPSULE BOTTLE14/07/2022
695NDA/MAL/HDP/10834MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDPANSIPTIN 100SITAGLIPTIN HYDROCHLORIDE100MGSAG MANUFACTURING S.L-CARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAIN |INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER06/06/2023 00:00
696NDA/MAL/HDP/10835MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDPANSIPTIN 50SITAGLIPTIN HYDROCHLORIDE50MGSAG MANUFACTURING S.L-CARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAIN |INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X18.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER06/06/2023 00:00
697NDA/MAL/HDP/10836MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDPANSIPTIN 25SITAGLIPTIN HYDROCHLORIDE25MGSAG MANUFACTURING S.L-CARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAIN |INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X16.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER06/06/2023 00:00
698NDA/MAL/HDP/10838SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTDTATA UGANDA LIMITEDDOLUTEGRAVIR TABLETS 50MGDOLUTEGRAVIR SODIUM50MGSHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD, 1479, ZHANGHENG ROAD, CHINA (SHANGHAI) PILOT FREE TRADE ZONE, SHANGHAI 201203 - CHINACHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET CONTAINER06/06/2023
699NDA/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 INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE06/06/2023
700NDA/MAL/HDP/1084DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE4MGDAWA LTD, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
701NDA/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 INDIAINDIAORAL TOPICAL SPRAYS WITHOUT GAS 1.0X1.0X50.0 ML CONTAINER06/06/2023
702NDA/MAL/HDP/10845MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTURBOVAS-20ROSUVASTATIN CALCIUM20MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER25/05/2023
703NDA/MAL/HDP/10848 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDMEFENA FORTE-500MEFENAMIC ACID500MGAGOG PHARMA LIMITED .-PLOT 33, SECTOR II THE VASAI TALUKA INDUSTIRAL COOP ESTE LTD GAURAIPADA, VASAI (E) DIST. THANE-401208 |INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER25/05/2023 00:00
704NDA/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/TURKEYTURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER03/05/2023
705NDA/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
706NDA/MAL/HDP/10855M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDTECAVIR 0.5ENTECAVIR MONOHYDRATE0.5MGHETERO LABS LIMITED (UNIT V)-SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER25/05/2023
707NDA/MAL/HDP/10856MS PHARMA JORDAN CO.LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDKEPAM 500MG/5MLLEVETIRACETAM500MG/5MLMS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE.JORDANPARENTERAL ORDINARY VIALS 1.0X10.0X5.0 ML VIAL (CLEAR GLASS VIAL)03/05/2023
708NDA/MAL/HDP/1086SHOSAAN ASIC PACIFICRENE PHARMACY LTDSYNOGEN TABLETSDIACEREIN + METHYL SULPHONYL METHANE + GLUCOSAMINE SULPHATE 50MG +250MG + 750MGNEM LABORATORIES LIMITED, 133 KRISHNA IND. ESTATE, VASAI (E),
THANE €“ 401 210, MAHARASHTRA €“ INDIA		INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
709NDA/MAL/HDP/10862MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBIFRIL 7.5MGZOFENOPRIL CALCIUM7.5MGA. MENARINI MANUFACTURING LOGISTICS AND SERVICES SRL, VIA CAMPO DI PILE 67100 L'AQUILA (AQ)ITALYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X12.0 TABLET BLISTER25/05/2023
710NDA/MAL/HDP/10865MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDLOREZELORATADINE10MGMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND |THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X5.0X1.0X1.0X10.0 CAPSULE BLISTER02/06/2023 00:00
711NDA/MAL/HDP/10874: ALKEM LABORATORIES LIMITEDˆŠABACUS PHARMA (AFRICA) LIMITEDPAN IVPANTOPRAZOLE SODIUM40MGEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X40.0 MG VIAL (+ 10 ML OF 0.9%W/V SODIUM CHLORIDE INJECTION, LDPE AMPOULE)17/08/2023
712NDA/MAL/HDP/10878LUPIN LIMITED-AIVEEN (U) LIMITEDLINEZOID 600 MG TABLETSLINEZOLID600MGLUPIN LTD, 198-202, NEW INDUSTRIAL AREA NO. 2, MANDIDEEP, BHOPAL-462 046, DIST. RAISEN, MADIA PRADESH INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER05/09/2023
713NDA/MAL/HDP/10879LUPIN LIMITED-AIVEEN (U) LIMITEDISONIAZID TABLETS 300MGISONIAZID300MGLUPIN LIMITED , A-28/1 MIDC CHIKALTHANA AURANGABADINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER05/09/2023
714NDA/MAL/HDP/10881MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDPANFOR PR-750METFORMIN HYDROCHLORIDE750MGINVENTIA HEALTHCARE LIMITED, F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - INDIAINDIAORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
715NDA/MAL/HDP/10882BHARAT SERUMS & VACCINES LTD.ABACUS PHARMA (AFRICA) LIMITEDFOLIGRAF 1200 IURECOMBINANT - HUMAN FOLLICLE STIMULATING HORMONE (R-HFSH)1200IU/VIAL (MULTIDOSE)BHARAT SERUM AND VACCINES LIMITED, PLOT NO. K-27 ADDITIONAL M.I.D.C INDIAINDIAPARENTERAL ORDINARY DRY AMPOULES 1.0X1.0 AMPOULE AMPOULE 1 PREFILLED SYRINGE OF DILUENT + 15 DISPOSABLE SYRINGES]17/08/2023
716NDA/MAL/HDP/10883 CIPLA LTD.ABACUS PHARMA (AFRICA) LIMITEDDAPAGLIFLOZIN TABLETS 10 MGDAPAGLIFLOZIN PROPANEDIOL10MGCIPLA LIMITED, PLOT NOS. L-139, S-103 & M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA, 403 722 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER17/08/2023
717NDA/MAL/HDP/10886LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDCLOTRILIN-VCLOTRIMAZOLE2%W/WLINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA |INDIA | VAGINAL CREAMS 1.0X1.0X15.0 G TUBE28/08/2023 00:00
718NDA/MAL/HDP/10890M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDZIQUANTAPRAZIQUANTEL600MGHETERO LABS LIMITED (UNIT V)-SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER28/08/2023
719NDA/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 |INDIA | TOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE28/08/2023 00:00
720NDA/MAL/HDP/10894REYOUNG PHARMACEUTICAL CO LTDBIOGEN PHARMA LIMITEDFRUSOGENFUROSEMIDE20MG/2MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE05/09/2023
721NDA/MAL/HDP/10896REYOUNG PHARMACEUTICAL CO LTDBIOGEN PHARMA LIMITEDAMPIGENAMPICILLIN SODIUM + CLOXACILLIN SODIUM(250MG + 250MG)VIALREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS 1.0X50.0X0.5 G VIAL05/09/2023
722NDA/MAL/HDP/10900DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDTRAMADOL DENKTRAMADOL HYDROCHLORIDE100MG/2 MLSOLUPHARM GMBH , INDUSTRIESTRASSE 3, 34212 MELSUNGENGERMANYPARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X2.0 ML AMPOULE28/08/2023
723NDA/MAL/HDP/10903MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDBIDSIPTINVILDAGLIPTIN50MGSAG MANUFACTURING S.L, CARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAINSPAINORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
724NDA/MAL/HDP/10904MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDUROKA PLUSDUTASTERIDE + TAMSULOSIN HYDROCHLORIDE0.5MG + 0.4MGSAG MANUFACTURING S.L, CARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAINSPAINORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER17/08/2023
725NDA/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
726NDA/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
727NDA/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
728NDA/MAL/HDP/10915DAVIMED PHARMA LIMITEDDAVIMED PHARMA LIMITEDDAVICEF 1 GCEFTRIAXONE SODIUM1G/VIALINNOVA CAPTAB PVT. LTD, 1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)|INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X10.0 ML VIAL17/08/2023
729NDA/MAL/HDP/10918BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDESUPRONEESOMEPRAZOLE SODIUM40 MG/VIALBLISS INDASI LIFESCIENCE PRIVATE LIMITED, PLOT NO. 73 TO 76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN- 396 210INDIAPARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL + 1*10 ML, SODIUM CHLORIDE IN LDPE PACK17/08/2023
730NDA/MAL/HDP/10919BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSANFIXIME 400CEFIXIME TRIHYDRATE400MGEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER05/09/2023
731NDA/MAL/HDP/10922LABORATORY&ALLIED LTDROYAL PHARMA 2011 LIMITEDLABCLAV 1G TABLETSAMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE875MG + 125MGLABORATORY & ALLIED LTD -PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, NEXT TO LIBRA HOUSE, MOMBASA ROAD- NAIROBI - KENYA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X2.0X7.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER05/09/2023
732NDA/MAL/HDP/10923BAROQUE PHARMACEUTICALS PVT LTDJEET PHARMACEUTICALS LIMITEDROSUSTAR 10MGROSUVASTATIN CALCIUM10MGBAROQUE PHARMACEUTICALS PVT. LTD, PLOT 192/2&3, SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER05/09/2023
733NDA/MAL/HDP/10928FAROMED LIFESCIENCES LLPABACUS PHARMA (AFRICA) LIMITEDFIX-ACEFIXIME TRIHYDRATE100MG/5MLTHE ACME LABORATORIES LIMITED, DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESHBANGLADESHORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X75.0 ML BOTTLE17/08/2023
734NDA/MAL/HDP/10931UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDUNIDROL 10ALFUZOSIN HYDROCHLORIDE10 MGUNICHEM LABORATORIES LTD, UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205INDIAORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
735NDA/MAL/HDP/10933BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDP-ALAXINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE20 MG + 160 MGBLISS GVS PHARMA LIMITED, 10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X3.0 TABLET BLISTER,1.0X2.0X3.0 TABLET BLISTER17/08/2023
736NDA/MAL/HDP/10934FAROMED LIFESCIENCES LLPABACUS PHARMA (AFRICA) LIMITEDALERCONOLOPATADINE HYDROCHLORIDE1 MG/MLTHE ACME LABORATORIES LIMITED, DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESHBANGLADESHOPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE17/08/2023
737NDA/MAL/HDP/10935FAROMED LIFESCIENCES LLPABACUS PHARMA (AFRICA) LIMITEDSUPERPIME 1G IM/IV INJECTIONCEFEPIME HYDROCHLORIDE1 G/VIALTHE ACME LABORATORIES LIMITED, DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESHBANGLADESHPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL17/08/2023
738NDA/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 |INDIA | OPHTHALMIC DROPS 1.0X1.0X10.0 ML BOTTLE05/09/2023 00:00
739NDA/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 |INDIA | OPHTHALMIC DROPS 1.0X1.0X10.0 ML BOTTLE05/09/2023 00:00
740NDA/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 099INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2013
741NDA/MAL/HDP/10948WALLACE PHARMACEUTICALS PVT. LTDSTAR PHARMACEUTICALS LTDFLUCOLDPARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENAMINE MALEATE500 MG + 10 MG + 2 MGWALLACE PHARMACEUTICALS PVT LTD, BHATIAN, NALAGARH, DIST. SOLAN HP 174101INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X5.0X10.0 TABLET BLISTER,1.0X5.0X1.0X10.0 TABLET BLISTER05/09/2023
742NDA/MAL/HDP/10949BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDCLAMOXIN-375 TABLETSAMOXICILLIN SODIUM + POTASSIUM CLAVULANATE250MG + 125 MGMEDOPHARM PVT LIMITED, NO. 50 KAYARAMBEDU VILLAGE, GUDUVANCHERY-603202INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER29/08/2023
743NDA/MAL/HDP/1095MICRO LABS LTDLABOREX UGANDA LIMITEDEROSTINE-20EBASTINE20MGMICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER01/07/2012
744NDA/MAL/HDP/10950 SUN PHARMACEUTICAL INDUSTRIES LIMITED -STAR PHARMACEUTICALS LTDDICORATE ER 500DIVALPROEX SODIUM500 MGSUN PHARMA LABORATORIES LIMITED, 6-9, EPIP, KARTHOLI, BARI BRAHMANA, JAMMU - 181133 (JAMMU AND KASHMIR) - INDIAINDIAORAL SOLID RETARD COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER17/08/2023
745NDA/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, MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X60.0 TABLET CONTAINER17/08/2023
746NDA/MAL/HDP/10964RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAZIRENAZITHROMYCIN DIHYDRATE500MGRENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER17/08/2023
747NDA/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 STATEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER17/08/2023
748NDA/MAL/HDP/10968HALEWOOD LABORATORIES PVT. LTD.AIVEEN (U) LIMITEDELECTRORUSH POWDER ORS BPSODIUM CHLORIDE + POTASSIUM CHLORIDE + TRISODIUM CITRATE DIHYDRATE + DEXTROSE ANHYDROUS2.60 G + 1.50 G + 2.90 G + 13.50 GHALEWOOD LABORATORIES PVT. LIMITED, 319, PHASE - II, GIDC, VATVA, AHMEDABAD - 382445, GUJARATINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X10.0X20.5 G SACHET17/08/2023
749NDA/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 AURANGABADINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE17/08/2023
750NDA/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 - INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0X1.0 ML AMPOULE17/08/2023
751NDA/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
752NDA/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
753NDA/MAL/HDP/10980 CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDMEFENEC PLUSMEFENAMIC ACID + DICYCLOMINE HYDROCHLORIDE250 MG + 20 MGRAVIAN LIFE SCIENCE PVT. LIMITED, PLOT NO. 34, SECTOR: 8A, SIDCUL, IIE, HARIDWAR - 249403, UTTARAKHANDINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER29/08/2023
754NDA/MAL/HDP/10986THE SEARLE COMPANY LIMITEDSURGIPHARM (U) LIMITEDJENTIN METSITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE50 MG + 1000 MGTHE SEARLE COMPANY LIMITED, F-319, S.I.T.E KARACHI 75530 - PAKISTANPAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER17/08/2023
755NDA/MAL/HDP/10987LUPIN LIMITED-AIVEEN (U) LIMITEDLAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 300MG AND 300 MGLAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE300 MG + 300 MGLUPIN LTD, PLOT NO. 6A, SECTOR 17, SPECIAL ECOOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER17/08/2023
756NDA/MAL/HDP/10989M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDBINFIN 5FINASTERIDE5MGHETERO LABS LIMITED (UNIT III)...-22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER29/08/2023
757NDA/MAL/HDP/1099GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDMOMATE F CREAMFUSIDIC ACID+MOMETASONE FUROATE2.1%W/W + 0.1W/WGLENMARK PHARMACEUTICALS LTD UNIT II., UNIT II VILLAGE BHATTANWALA NALAGARH DIST SOLAN HIMACHAL PRADESHINDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE01/07/2012
758NDA/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
759NDA/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
760NDA/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
761NDA/MAL/HDP/10998ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDMOCINMOXIFLOXACIN HYDROCHLORIDE400MG/100MLABACUS PARENTERAL DRUGS LIMITED, PLOT 114, BLOCK 191, KINGAUGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML BOTTLE17/08/2023
762NDA/MAL/HDP/1100GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIR SKIN CREAMACICLOVIR5% W/WAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE,1.0X5.0 G TUBE01/07/2013
763NDA/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-403526INDIAVAGINAL CREAMS 1.0X1.0X40.0 G TUBE29/08/2023
764NDA/MAL/HDP/11003MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDBAROLERABEPRAZOLE20MGNAPROD LIFE SCIENCES PVT. LTD, G-17/1, MIDC TARAPUR IND. AREA, BOISAR, 401506 MAHARASHTRAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X20.0 MG VIAL17/08/2023
765NDA/MAL/HDP/11004FAROMED LIFESCIENCES LLPABACUS PHARMA (AFRICA) LIMITEDFAST 125PARACETAMOL125MGTHE ACME LABORATORIES LIMITED, DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESHBANGLADESHRECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP17/08/2023
766NDA/MAL/HDP/11015AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDHYDROCORTISONE CREAM BPHYDROCORTISONE ACETATE1% W/WCIRON DRUGS PHARMACEUTICALS PRIVATE LIMITED, PLOT NO. 35-37, 43-45, CFC-B, DEWAN UDHYOG NAGAR, ALIYALI, PALGHAR €“ 401404, MAHARASHTRAINDIATOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE12/13/2023
767NDA/MAL/HDP/11016AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEDOBOOK 15LENALIDOMIDE15MGEUGIA PHARMA SPECIALITIES LIMITED, SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X7.0 CAPSULE BLISTER31/01/2024
768NDA/MAL/HDP/11017AUROBINDOPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEDOBOOK 25LENALIDOMIDE25MGEUGIA PHARMA SPECIALITIES LIMITED, SURVEY 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
769NDA/MAL/HDP/11018AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEDWINMEDROXYPROGESTERONE150MG/MLEUGIA PHARMA SPECIALITIES LIMITED, SURVEY 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
770NDA/MAL/HDP/11019AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEDOBOOK 5LENALIDOMIDE 5MGEUGIA PHARMA SPECIALITIES LIMITED, SURVEY 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
771NDA/MAL/HDP/11020ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDIBUPLUSIBUPROFEN + PARACETAMOL100MG/125MGM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED, HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X60.0 ML BOTTLE12/13/2023
772NDA/MAL/HDP/11021ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDINTAFERONIRON SUCROSE 100MG/5ML.M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED, HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X5.0 ML AMPOULE12/13/2023
773NDA/MAL/HDP/11022ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDCEFIXIME QUIX DISPERSIBLE TABLETS 200MGCEFIXIME TRIHYDRATE200MGM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED, HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
774NDA/MAL/HDP/11023ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDMOXVIDAMOXICILLIN TRIHYDRATE125 MG/5 MLM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED, HILL-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
775NDA/MAL/HDP/11024LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDCLONAPIN-2CLONAZEPAM2MGLINCOLN PHARMACEUTICALS LTD, 10, 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
776NDA/MAL/HDP/11025LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDDYGYLMETRONIDAZOLE BENZOATE125MG/5MLLINCOLN PHARMACEUTICALS LTD, 10, 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
777NDA/MAL/HDP/11026LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDTELMISINTELMISARTAN40 MGLINCOLN PHARMACEUTICALS LTD, 10, 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
778NDA/MAL/HDP/11027ABACUS (A) PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCEFIMCZ-400CEFIXIME400 MGZEISS PHARMA LIMITED, IGC,SIDCO, PHASE II, SAMBA, JAMMU - 184121,(J&K)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER12/13/2023
779NDA/MAL/HDP/11028AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDAPLENE 50PREGABALIN50MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER25/01/2024
780NDA/MAL/HDP/11029AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDAPLENE 75PREGABALIN75MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER25/01/2024
781NDA/MAL/HDP/1103GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIN CREAMNEOMYCIN SULPHATE0.5% W/WAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2014
782NDA/MAL/HDP/11030AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDAPLENE 150PREGABALIN150MGAJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER25/01/2024
783NDA/MAL/HDP/11031M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDNIZACARD 500RANOLAZINE500MGHETERO LABS PRIVATE LIMITED UNIT III, SURVEY 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
784NDA/MAL/HDP/11032M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDNIZACARD 1000RANOLAZINE1000MGHETERO LABS PRIVATE LIMITED UNIT III, SURVEY 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
785NDA/MAL/HDP/11033KESAR PHARMAJEET PHARMACEUTICALS LIMITEDFLUPLEXPARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE + CAFFEINE ANHYDROUS500MG + 10MG + 2MG + 30MGKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X50.0X1.0X4.0 TABLET STRIP30/01/2024
786NDA/MAL/HDP/11034ARCELIA LIFE SCIENCES LTD.PLUTO PHARMACEUTICALS LIMITEDARCELIA® ESOMEPRAZOLE TABLETS 40 MGESOMEPRAZOLE MAGNESIUM DIHYDRATE40 MGASSOCIATED BIOTECH, VILLAGE: KISHANPURA, GUGUMAJRA ROAD, BADDI THE: NALAGARH HIMACHAL PRADESH 174101 - INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER12/13/2023
787NDA/MAL/HDP/11035ARCELIA LIFE SCIENCES LTD.PLUTO PHARMACEUTICALS LIMITEDARCELIA® ESOMEPRAZOLE TABLETS 20 MGESOMEPRAZOLE MAGNESIUM DIHYDRATE20 MGASSOCIATED BIOTECH, VILLAGE: KISHANPURA, GUGUMAJRA ROAD, BADDI THE: NALAGARH HIMACHAL PRADESH 174101 - INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER12/13/2023
788NDA/MAL/HDP/11036ARCELIA LIFE SCIENCES LTD.PLUTO PHARMACEUTICALS LIMITEDDROCELIADROTAVERINE HYDROCHLORIDE40 MG/2 MLSANJAR PHARMA LLP, SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X2.0 ML AMPOULE12/13/2023
789NDA/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
790NDA/MAL/HDP/11039ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDLIGNOCAINLIDOCAINE20 MG/MLM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED, HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X30.0 ML VIAL12/13/2023
791NDA/MAL/HDP/1104HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDLIPIDUCE 10ATORVASTATIN10MGHOVID BERHAD,, LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAKMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X3.0 TABLET BLISTER01/07/2014
792NDA/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
793NDA/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
794NDA/MAL/HDP/11043AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDDIAZAC 5DAPAGLIFLOZIN5MGAJANTA PHARMA LIMITED, PLOT 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
795NDA/MAL/HDP/11044AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDDIAZAC 10DAPAGLIFLOZIN10MGAJANTA PHARMA LIMITED, PLOT 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
796NDA/MAL/HDP/11047MICRO LABS LIMITEDLABOREX UGANDA LIMITEDMURAXAL -10ALFUZOSIN HYDROCHLORIDE10MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID RETARD TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
797NDA/MAL/HDP/11048GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAPRETUDE 600 MGCABOTEGRAVIR200MG/MLGLAXO OPERATIONS UK LIMITED, HARMIRE ROAD, BARNARD CASTLE, DURHAM, DL 12 8DT - UNITED KINGDOMUNITED KINGDOMPARENTERAL ORDINARY VIALS 1.0X1.0X3.0 ML VIAL,1.0X25.0X3.0 ML VIAL12/13/2023
798NDA/MAL/HDP/11049NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDXYM-KIDSIMETHICONE + DILL OIL + FENNEL OIL40MG + 0.005ML + 0.0007MLNEXT WAVE, RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P)INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X15.0 ML BOTTLE12/13/2023
799NDA/MAL/HDP/11050SURGE LABORATORIES (PVT) LTD,HEALTHCARE LTD.SERGIFEX 1GCEFTRIAXONE SODIUM1 G/VIALSURGE LABORATORIES (PVT) LTD.,,, 10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN.PAKISTANPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 1*10ML, CLEAR GLASS AMPOULE OF WATER FOR INJECTION12/13/2023
800NDA/MAL/HDP/11051SURGE LABORATORIES (PVT) LTD,HEALTHCARE LTD.SERGIFEX 2GCEFTRIAXONE SODIUM2 G/VIALSURGE LABORATORIES (PVT) LTD.,,, 10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN.PAKISTANPARENTERAL ORDINARY DRY VIALS 1.0X2.0 G VIAL + 2*10ML, CLEAR GLASS AMPOULE OF WATER FOR INJECTION12/13/2023
801NDA/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
802NDA/MAL/HDP/11053ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDOLODINEOLOPATADINE HYDROCHLORIDE0.1% W/VABACUS PARENTERAL DRUGS LIMITED, PLOT 114, BLOCK 191, KINGAUGANDAOPHTHALMIC DROPS 1.0X1.0X5.0 ML CONTAINER12/13/2023
803NDA/MAL/HDP/11054ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDTORATOBRAMYCIN SULPHATE0.3% W/VABACUS PARENTERAL DRUGS LIMITED, PLOT 114, BLOCK 191, KINGAUGANDAOPHTHALMIC DROPS 1.0X1.0X5.0 ML CONTAINER12/13/2023
804NDA/MAL/HDP/11055ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDTORA-DTOBRAMYCIN SULPHATE + DEXAMETHASONE SODIUM PHOSPHATE0.3%W/V + 0.1%W/VABACUS PARENTERAL DRUGS LIMITED, PLOT 114, BLOCK 191, KINGAUGANDAOPHTHALMIC DROPS 1.0X1.0X5.0 ML CONTAINER12/13/2023
805NDA/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
806NDA/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 BLISTER25/01/2024
807NDA/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
808NDA/MAL/HDP/11059AURA LIFECARE PVT. LTD.REDDYS PHARMA LIMITEDAURADERM-0.05CLOBETASOL0.05%W/WAURA LIFECARE PRIVATE LIMITED, SURVEY 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
809NDA/MAL/HDP/1106 EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCESUNITED HEALTHCARE DISTRIBUTORS LTDDIACEREINDIACEREIN50MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES, 176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER01/07/2013
810NDA/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 VIAL + 10ML WATER FOR INJECTION12/13/2023
811NDA/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
812NDA/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
813NDA/MAL/HDP/11063PHARMA BAVARIA INTERNACIONAL(PBI) PORTUGUALGOODMAN INTERNATIONAL LTDCOMBOFUSIVPARACETAMOL + IBUPROFEN10MG/ML + 3MG/MLS.M. FARMACEUTICI S.R.L, ZONA INDUSTRIALE, 85050 TITO (PZ)ITALYPARENTERAL ORDINARY VIALS 1.0X10.0X100.0 ML VIAL25/01/2024
814NDA/MAL/HDP/11064MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDISONIAZID DISPERSIBLE TABLETS 100 MGISONIAZID100 MGOXALIS LABS LIMITED, VILLAGE THEDA, P.O LODHIMAJRA, TEHSIL BADDI DIST: SOLAN (H.P.) PIN CODE: 174101 - INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET STRIP30/01/2024
815NDA/MAL/HDP/11065JAMJOOM PHARMACEUTICALS COMPANYMU PHARMA CO -SMC LIMITEDAROXMOXIFLOXACIN HYDROCHLORIDE0.5% W/VJAMJOOM PHARMACEUTICALS COMPANY, PLOT 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
816NDA/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
817NDA/MAL/HDP/1107SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LTD -MBARARAHEPATITIS B VACCINE(RDNA) (PAEDIATRIC))HEPATITIS B VACCINE(RDNA)10MCG /0.5MLSERUM INSTITUTE OF INDIA LTD, 212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY I M VIALS 1.0X25.0X5.0 ML VIAL (10 DOSES), 1.0X10.0X0.5 ML VIAL (1 DOSE)01/07/2005
818NDA/MAL/HDP/11070MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJITRIT-5TOFACINIB 5MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X15.0 TABLET BLISTER12/13/2023
819NDA/MAL/HDP/11071MYLAN PHARMACEUTICALS PRIVATE LIMITED, INDIAKIMSY MEDS LTDOGIVRI„¢ 440 MGTRASTUZUMAB440MG/VIALBIOCON BIOLOGICS LIMITED, SPECIAL 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
820NDA/MAL/HDP/11072MEDOPHARMNUGEN PHARMACEUTICALS UGANDA LIMITEDNUNINEQUININE SULFATE300MGMEDOPHARM, NO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER12/13/2023
821NDA/MAL/HDP/11073DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDPARACO-DENK 500/30PARACETAMOL + CODEINE PHOSPHATE HEMIHYDRATE500 MG + 30 MGBENE-ARZNEIMITTEL GMBH, PRODUCTION 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
822NDA/MAL/HDP/11074MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDFAMYTECMISOPROSTOL200MCGMYLAN LABORATORIES LIMITED, PLOT 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
823NDA/MAL/HDP/11075HEALTH LINK PHARMACY LTDHEALTH LINK PHARMACY LIMITEDROLXIN ODDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE120 MG + 960 MGEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER12/13/2023
824NDA/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 1.0X50.0X3.0 TABLET BLISTER,1.0X100.0X3.0 TABLET BLISTER12/13/2023
825NDA/MAL/HDP/11078BROOKES PHARMA (PRIVATE) LIMITEDHARLEYS UGANDA LIMITEDB-LACTLACTULOSE3.35GM/5MLFRESENIUS KABI AUSTRIA GMBH, ESTERMANNSTRASSE 17, A-4020 LINZAUSTRIAORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE02/02/2024
826NDA/MAL/HDP/11079MEDOPHARMPLANET PHARMACEUTICALS UGANDA LTDMIRAFOLICFOLIC ACID5MGMEDOPHARM, NO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER02/02/2024
827NDA/MAL/HDP/11080MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-AMHOLMESARTAN MEDOXOMIL + AMLODIPINE BESILATE + HYDROCHLOROTHIAZIDE20MG + 5MG + 12.5MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
828NDA/MAL/HDP/11081INFUGEN PHARMA PVT. LTD.GITTOES PHARMACEUTICALS LIMITEDINFUROXIMCEFUROXIME SODIUM750MGZEISS PHARMACEUTICALS PRIVATE LIMITED, PLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.)INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X750.0 MG VIAL02/02/2024
829NDA/MAL/HDP/11082UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDVIVAZAC PLUSIRBESARTAN + HYDROCHLOROTHIAZIDE150 MG + 12.5 MGUNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY, AL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
830NDA/MAL/HDP/11083ASPIRO PHARMA LIMITED.AIVEEN (U) LIMITEDCANDIVOR 200 MG/VIALVORICONAZOLE200MGASPIRO PHARMA LIMITED, SY. 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
831NDA/MAL/HDP/11084MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDINVEL FORTE LMETRONIDAZOLE + MICONAZOLE NITRATE + LIDOCAINE750 MG + 200 MG + 100 MGBLISS GVS PHARMA LTD, PLOT NO. 11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI, PALGHAR, MAHARASHTRA 401404, INDIAINDIAVAGINAL SUPPOSITORIES 1.0X2.0X7.0 SUPPOSITORY STRIP02/02/2024
832NDA/MAL/HDP/11085CACHET PHARMACEUTICALS PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDEMITINO INJECTIONONDANSETRON HYDROCHLORIDE4MG/2MLSAKAR HEALTHCARE PVT LTD, BLOCK 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
833NDA/MAL/HDP/11086BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDERYBRU 500ERYTHROMYCIN STEARATE500MGBRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER02/02/2024
834NDA/MAL/HDP/11087MS PHARMA JORDAN CO.LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDAMICINEAMIKACIN SULPHATE500MG/2MLMS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE.JORDANPARENTERAL ORDINARY VIALS 1.0X5.0X2.0 ML VIAL02/02/2024
835NDA/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
836NDA/MAL/HDP/1109DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE 2MG/5MLDAWA PHARMACEUTICALS LIMITED, PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE01/07/2014
837NDA/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
838NDA/MAL/HDP/11091SWISS GARNIER LIFE SCIENCES.REDDYS PHARMA LIMITEDSWIZGLIPT 100SITAGLIPTIN PHOSPHATE MONOHYDRATE100MGSWISS GARNIER LIFE SCIENCES, 21-23 INDUSTRIAL AREA, MEHATPUR, UNA DIST., HIMACHAL PRADESH - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
839NDA/MAL/HDP/11092SWISS GARNIER LIFE SCIENCES.REDDYS PHARMA LIMITEDSWIZGLIPT 50SITAGLIPTIN PHOSPHATE MONOHYDRATE50MGSWISS GARNIER LIFE SCIENCES, 21-23 INDUSTRIAL AREA, MEHATPUR, UNA DIST., HIMACHAL PRADESH - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
840NDA/MAL/HDP/11093MS PHARMA JORDAN CO.LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDXERATECIRON SUCROSE100MGMS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE.JORDANPARENTERAL ORDINARY VIALS 1.0X5.0X5.0 ML VIAL02/02/2024
841NDA/MAL/HDP/11094BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDFETNAL 500CEFUROXIME AXETIL500MGBRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER02/02/2024
842NDA/MAL/HDP/11098VERVE HUMAN CARE LABORATORIESABACUS PHARMA (AFRICA) LIMITEDADEVERADRENALINE ACID TARTRATE1MG/MLVERVE HUMAN CARE LABORATORIES, PLOT NO. 15A PHARMACITY, SELAQUI, DEHRADUN, UTTARAKHAND, 248011, INDIA.INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE02/02/2024
843NDA/MAL/HDP/11101SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDCLARITHROMYCIN 500 MGCLARITHROMYCIN500MGSANDOZ S.R.L, STR. LIVEZENI NR. 7A 540472 TARGU-MURES ROMANIAROMANIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER02/02/2024
844NDA/MAL/HDP/11102ENCORE HEALTHCARE PVT. LTD.REDDYS PHARMA LIMITEDONTADEX 50MGTRAMADOL HYDROCHLORIDE50MGENCORE HEALTHCARE PVT LTD, D-5, MIDC AREA, PAITHAN- 431148, DIST. AURANGABAD, MAHARASHTRA - INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER02/02/2024
845NDA/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
846NDA/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
847NDA/MAL/HDP/11105AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD. HEALTHCARE LTD.TELOSINTAMSULOSIN HYDROCHLORIDE0.4MGAL FAZAL PHARMA INDUSTRIES (PVT) LTD, PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTANPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER02/02/2024
848NDA/MAL/HDP/11106SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD., ROYAL PHARMA 2011 LIMITEDSCOTXONE-1GCEFTRIAXONE SODIUM1GM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED, HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.0 G VIAL02/02/2024
849NDA/MAL/HDP/11107 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDAZITO 500AZITHROMYCIN DIHYDRATE500MGZIM LABORATORIES LIMITED, B-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER02/02/2024
850NDA/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
851NDA/MAL/HDP/1111DAWA LIMITEDSUPER MEDIC LTDFAST-ACT GEL DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + LINSEED OIL + MENTHOL CRYSTALS1.16%W/W + 10%W/W + 3%W/W + 5%W/WDAWA PHARMACEUTICALS LIMITED, PLOT 7879, BABA DOGO ROAD RUARAKAKENYATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE01/07/2013
852NDA/MAL/HDP/11111RUSAN PHARMA LTD.NORVIK ENTERPRISES LIMITEDADDNOKBUPRENORPHINE HYDROCHLORIDE8MGRUSAN PHARMA LTD, KHASRA NO. 122MI, CENTRAL HOPE TOWN, BEHIND PHARMA CITY, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIA| RUSAN PHARMA LIMITED, PLOT 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
853NDA/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
854NDA/MAL/HDP/11113ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDATRONA-20ATORVASTATIN CALCIUM20MGZOTA HEATHCARE LIMITED, PLOT 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
855NDA/MAL/HDP/11114FAROMED LIFESCIENCES LLPABACUS PHARMA (AFRICA) LIMITEDAPTIN M 50/500 F/C TABLETVILDAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 500MGADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED, 7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER20/05/2024
856NDA/MAL/HDP/11115FAROMED LIFESCIENCES LLPABACUS PHARMA (AFRICA) LIMITEDSITOMET 50/500SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE50 MG + 500 MGADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED, 7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER20/05/2024
857NDA/MAL/HDP/11116FAROMED LIFESCIENCES LLPABACUS PHARMA (AFRICA) LIMITEDSITOMET 50/1000SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE50 MG + 1000 MGADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED, 7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER20/05/2024
858NDA/MAL/HDP/11117FAROMED LIFESCIENCES LLPABACUS PHARMA (AFRICA) LIMITEDFAST 250 SUPPOSITORYPARACETAMOL250MGTHE ACME LABORATORIES LIMITED, DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESHBANGLADESHRECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP02/02/2024
859NDA/MAL/HDP/11118LUPIN LIMITED-AIVEEN (U) LIMITEDMOXIFLOXACINMOXIFLOXACIN HYDROCHLORIDE400 MGLUPIN LIMITED, UNIT-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
860NDA/MAL/HDP/11119AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDETIMICOL 10EZETIMIBE10MGAUROBINDO 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 FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
861NDA/MAL/HDP/11120AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVALABIN 500VALACICLOVIR HYDROCHLORIDE500MGAUROBINDO PHARMA LIMITED, UNIT III, SURVEY 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
862NDA/MAL/HDP/11128ATCO LABORATORIES LIMITEDHARLEYS UGANDA LIMITEDBETAMET-NBETAMETHASONE AS VALERATE + NEOMYCIN SULPHATE0.1% W/W + 0.5% W/WATCO LABORATORIES LIMITED, B-18, S.I.T.E, KARACHI - 74700PAKISTANTOPICAL EXTERNAL OINTMENTS 1.0X1.0X15.0 G TUBE12/13/2023
863NDA/MAL/HDP/11129EAST AFRICAN (INDIA) OVERSEASROYAL PHARMA 2011 LIMITEDPARARIV-IIBUPROFEN + PARACETAMOL100 MG + 162.5 MGEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE12/13/2023
864NDA/MAL/HDP/1113MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-YELLOWMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS PVT. LTD. , UNIT-1, VILLAGE- ISSAPUR, DAPPAR, POST- DAPPAR, PUNJAB- 140506INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE01/07/1997
865NDA/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), INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
866NDA/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 - INDIAINDIAORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER01/02/2024
867NDA/MAL/HDP/11136KESAR PHARMAABACUS PHARMA (AFRICA) LIMITEDWOMTRAALBENDAZOLE400 MGKESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X1.0 TABLET BLISTER12/13/2023
868NDA/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,INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET CONTAINER,1.0X180.0 TABLET CONTAINER12/13/2023
869NDA/MAL/HDP/11138CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCABALIN 150PREGABALIN150 MGCACHET PHARMACEUTICALS PVT LTD ., VILLAGE THANA, BADDI, TEHSIL-NALAGARH DIST. SOLAN, HIMACHAL PRADESH-173205INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X2.0X12.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER12/13/2023
870NDA/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,INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE12/13/2023
871NDA/MAL/HDP/1114SHOSAAN ASIC PACIFICRENE PHARMACY LTDTRANGEL ULTRADICLOFENAC/METHYL SALICYLATE/MENTHOL/CAPSICUM OLEORESIN10MG/80MG/60MG/0.15MGNEM LABORATORIES LIMITED, 133 KRISHNA IND. ESTATE, VASAI (E),
THANE €“ 401 210, MAHARASHTRA €“ INDIA		INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G CONTAINER01/07/2012
872NDA/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 - CHINACHINAPARENTERAL ORDINARY VIALS 1.0X1.0X0.5 ML VIAL,1.0X1.0X0.5 ML PRE- FILLED SYRINGE12/13/2023
873NDA/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 - CHINACHINAPARENTERAL ORDINARY VIALS 1.0X1.0X1.0 ML VIAL,1.0X1.0X1.0 ML PRE- FILLED SYRINGE12/13/2023
874NDA/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 INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.0 G VIAL12/13/2023
875NDA/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-74900PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
876NDA/MAL/HDP/11144CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDQUALITY 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 PARKUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE12/13/2023
877NDA/MAL/HDP/11145NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDCADZOLE-VCLOTRIMAZOLE100 MGNEXT WAVE, RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P)INDIAVAGINAL TABLETS 1.0X1.0X6.0 TABLET STRIP12/13/2023
878NDA/MAL/HDP/11147UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDMEMTIN 10MEMANTINE HYDROCHLORIDE10 MGUNICHEM LABORATORIES LTD, UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
879NDA/MAL/HDP/11148ATCO LABORATORIES LIMITEDHARLEYS UGANDA LIMITEDCONAZ CREAMKETOCONAZOLE2% W/WATCO LABORATORIES LIMITED, B-18, S.I.T.E, KARACHI - 74700PAKISTANTOPICAL EXTERNAL CREAMS 1.0X1.0X10.0 G TUBE12/13/2023
880NDA/MAL/HDP/11149JAMJOOM PHARMACEUTICALS COMPANYMU PHARMA CO -SMC LIMITEDLICANLULICONAZOLE1% W/WCIPLA LTD, GOA UNIT V & UNIT X, L-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOASAUDI ARABIATOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE01/02/2024
881NDA/MAL/HDP/1115SKAGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDCALYZIDCALCIUM CARBONATE + L-LYSINE MONOHYDRCHLORIDE + VITAMIN D3 + ZINC 12.5 MG + 1.0MG + 0.1625MG + 0.766MGS KANT HEALTH CARE LTD, PLOT 1802 €“ 1805INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE01/07/2013
882NDA/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 - KENYAKENYAORAL 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 BLISTER01/02/2024
883NDA/MAL/HDP/11151BAROQUE PHARMACEUTICALS PVT LTDJEET PHARMACEUTICALS LIMITEDNUROQ 75PREGABALIN75 MGBAROQUE PHARMACEUTICAL PVT LTD, 192/2 & 3, SOKHADA, 388620, TA: KHAMHAT DIST. ANANT (GUJARAT)INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/02/2024
884NDA/MAL/HDP/11152BAROQUE PHARMACEUTICALS PVT LTDJEET PHARMACEUTICALS LIMITEDCOCELCELECOXIB200 MGBAROQUE PHARMACEUTICAL PVT LTD, 192/2 & 3, SOKHADA, 388620, TA: KHAMHAT DIST. ANANT (GUJARAT)INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/02/2024
885NDA/MAL/HDP/11153MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDXAFARIV 15RIVAROXABAN15 MGMYLAN LABORATORIES LIMITED, NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
886NDA/MAL/HDP/11154MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDXAFARIV 20RIVAROXABAN20 MGMYLAN LABORATORIES LIMITED, NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
887NDA/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. CHINACHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X15.0 ML VIAL12/13/2023
888NDA/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. CHINACHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X15.0 ML VIAL12/13/2023
889NDA/MAL/HDP/11157GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDDOVATO 50MG/300MGDOLUTEGRAVIR + LAMIVUDINE50 MG + 300 MGGLAXOSMITHKLINE, LLC, 1011 NORTH ARENDELL AVENUE ZEBULON, NORTH CAROLINA 27597UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE02/02/2024
890NDA/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
891NDA/MAL/HDP/11159AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDTIBAN 20TENEGLIPTIN HYDROBROMIDE HYDRATE20MGAJANTA PHARMA LIMITED, B-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
892NDA/MAL/HDP/11160ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDROSUNA-5ROSUVASTATIN CALCIUM5MGZOTA HEATHCARE LIMITED, PLOT 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
893NDA/MAL/HDP/11161CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDEMITINO-8 INJECTIONONDANSETRON HYDROCHLORIDE8MG/4MLEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0X4.0 ML AMPOULE02/02/2024
894NDA/MAL/HDP/11162UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDRABZOLRABEPRAZOLE SODIUM20MGNAPROD LIFE SCIENCES PVT. LTD, G-17/1, MIDC TARAPUR IND. AREA, BOISAR, 401506 MAHARASHTRAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X20.0 MG VIAL + 1*5ML LDPE BOTTLE OF WATER FOR INJECTION02/02/2024
895NDA/MAL/HDP/11164IDA FOUNDATYIONKIMSY MEDS LTDBENZATHINE BENZYLPENICILLIN 5MIUBENZATHINE BENZYLPENICILLIN5 MIUREYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINACHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X15.0 ML VIAL12/13/2023
896NDA/MAL/HDP/11165IDA FOUNDATYIONKIMSY MEDS LTDBENZATHINE BENZYLPENICILLIN 1MIUBENZATHINE BENZYLPENICILLIN1MIUREYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINACHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X15.0 ML VIAL01/02/2024
897NDA/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 BLISTER (EACH BLISTER CONTAINS 4 FILM COATED TABLETS AND 2 HARD GELATIN CAPSULES)21/02/2024
898NDA/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, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
899NDA/MAL/HDP/11168MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDXAGULANT 5APIXABAN5 MGMYLAN LABORATORIES LIMITED, NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
900NDA/MAL/HDP/11169IDA FOUNDATYIONKIMSY MEDS LTDDICLOFENAC SODIUMDICLOFENAC SODIUM75MG/3MLREYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X3.0 ML AMPOULE12/13/2023
901NDA/MAL/HDP/1117SHOSAAN ASIC PACIFICRENE PHARMACY LTDTETRACYCLINE EYE OINTMENT USP 1%TETRACYCLINE1%W/WNEM LABORATORIES LIMITED, 133 KRISHNA IND. ESTATE, VASAI (E),
THANE €“ 401 210, MAHARASHTRA €“ INDIA		INDIAOPHTHALMIC OINTMENTS 1.0X20.0X3.5 G TUBE01/07/2013
902NDA/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, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL + 1*10 ML, WATER FOR INJECTION IN LDPE AMPOULE12/13/2023
903NDA/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, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER12/13/2023
904NDA/MAL/HDP/11172ATCO LABORATORIES LIMITEDHARLEYS UGANDA LIMITEDGLANTRIMDORZOLAMIDE HYDROCHLORIDE + TIMOLOL MALEATE2%W/V + 0.5%W/VATCO LABORATORIES LIMITED, B-18, S.I.T.E, KARACHI - 74700PAKISTANOPHTHALMIC LIQUIDS 1.0X1.0X5.0 ML BOTTLE02/02/2024
905NDA/MAL/HDP/11173ATCO LABORATORIES LIMITEDHARLEYS UGANDA LIMITEDWINOLAP 0.1OLOPATADINE HYDROCHLORIDE0.1%W/VATCO LABORATORIES LIMITED, B-18, S.I.T.E, KARACHI - 74700PAKISTANOPHTHALMIC LIQUIDS 1.0X1.0X5.0 ML BOTTLE02/02/2024
906NDA/MAL/HDP/11174ATCO LABORATORIES LIMITEDHARLEYS UGANDA LIMITEDWINOLAP 0.2%OLOPATADINE HYDROCHLORIDE0.2%W/VATCO LABORATORIES LIMITED, B-18, S.I.T.E, KARACHI - 74700PAKISTANOPHTHALMIC LIQUIDS 1.0X1.0X2.5 ML BOTTLE02/02/2024
907NDA/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
908NDA/MAL/HDP/11176AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBORTEBINBORTEZOMIB3.5MGEUGIA PHARMA SPECIALITIES LIMITED, SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X3.5 MG VIAL (10ML GLASS VIAL)02/02/2024
909NDA/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
910NDA/MAL/HDP/1118EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDELAXIM 52.5TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR), (TNK-T-PA)52.5GENNOVA BIOPHARMACEUTICALS LIMITED, BLOCK 1, PLOT NO. P-1 AND P-2, ITBT PARK, PHASE II, MIDC, HINJAWADI, PUNE - 411057INDIAPARENTERAL ORDINARY I V VIALS 1.0X52.5 MG VIAL + (1*10ML AMPOULE WFI)01/07/2013
911NDA/MAL/HDP/11182INDIANA OPHTHALMICS SWASTIK PHARMACEUTICAL LTDAYZEECONAZITHROMYCIN DIHYDRATE1%W/WINDIANA OPHTHALMICS, 135, 136, 137, GIDC ESTATE, WADHWAN-363035INDIAOPHTHALMIC OINTMENTS 1.0X1.0X5.0 G TUBE02/02/2024
912NDA/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, GUJARATINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER12/13/2023
913NDA/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, INDIAINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE12/13/2023
914NDA/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, INDIAINDIATOPICAL EXTERNAL DUSTING POWDERS 1.0X50.0 G BOTTLE01/02/2024
915NDA/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, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER12/13/2023
916NDA/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, INDIAINDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER12/13/2023
917NDA/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, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0X1.0 ML AMPOULE12/13/2023
918NDA/MAL/HDP/11195FAROMED LIFESCIENCES LLPABACUS PHARMA (AFRICA) LIMITEDWINOP 60KETOROLAC TROMETHAMINE60MG/2MLTHE ACME LABORATORIES LIMITED, DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESHBANGLADESHPARENTERAL ORDINARY AMPOULES 1.0X1.0X2.0 ML AMPOULE12/13/2023
919NDA/MAL/HDP/11196FAROMED LIFESCIENCES LLPABACUS PHARMA (AFRICA) LIMITEDPERMINPERMETHRIN5%W/WTHE ACME LABORATORIES LIMITED, DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESHBANGLADESHTOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE12/13/2023
920NDA/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, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
921NDA/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, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0X2.0 ML VIAL12/13/2023
922NDA/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 - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
923NDA/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 - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/02/2024
924NDA/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 - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/02/2024
925NDA/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, 500101INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X2.0 ML VIAL12/13/2023
926NDA/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 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE01/02/2024
927NDA/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) 173205INDIATOPICAL EXTERNAL CREAMS 1.0X1.0X20.0 G TUBE01/02/2024
928NDA/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 213INDIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X1.0X500.0 ML BOTTLE12/13/2023
929NDA/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)INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X6.0X1.0X10.0 CAPSULE BLISTER01/02/2024
930NDA/MAL/HDP/11208ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDROZMET - 500METFORMIN500 MGEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER12/13/2023
931NDA/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, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0X1.0 ML AMPOULE12/13/2023
932NDA/MAL/HDP/1122ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCHLOR EAR DROPSCHLORAMPHENICOL5%W/VABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAOTIC DROPS 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL01/07/2013
933NDA/MAL/HDP/1123GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPAR PARACETAMOL500 MGAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER01/07/2012
934NDA/MAL/HDP/11230SERUM INSTITUTE OF INDIA PVT LTDNORVIK ENTERPRISES LIMITEDCYVACR21 MALARIA VACCINE (RECOMBINANT, ADJUVANTED)5µG OF MALARIA ANTIGEN & 50µG OF MATRIX-M1 PER DOSE OF 0.5MLSERUM INSTITUTE OF INDIA PVT LTD ., 212/2, HADAPSAR, PUNE- 411028, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X50.0X0.5 ML VIAL (1 DOSE), 1.0X50.0X1.0 ML VIAL (2 DOSE)22/03/2024
935NDA/MAL/HDP/11232AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPLERISTEMPLERIXAFOR24MG/1.2MLEUGIA PHARMA SPECIALITIES LIMITED, SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101INDIAPARENTERAL ORDINARY VIALS 1.0X1.0X1.2 ML VIAL22/03/2024
936NDA/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 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER22/03/2024
937NDA/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
938NDA/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
939NDA/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 LIMITED, SURVEY 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
940NDA/MAL/HDP/11237LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDPERILINMETOCLOPRAMIDE HYDROCHLORIDE 10MG/2MLLINCOLN PHARMACEUTICALS LTD, 10, 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
941NDA/MAL/HDP/11238LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDDESLORA-5DESLORATADINE5MGLINCOLN PHARMACEUTICALS LTD, 10, 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
942NDA/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 LTD, PLOT 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
943NDA/MAL/HDP/11241ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDTERBINAFINE TABLETS USP, 250 MGTERBINAFINE HYDROCHLORIDE250MGEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
944NDA/MAL/HDP/11242FAROMED LIFESCIENCES LLPABACUS PHARMA (AFRICA) LIMITEDSITAP 50SITAGLIPTIN PHOSPHATE MONOHYDRATE50MGADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED, 7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
945NDA/MAL/HDP/11243SUNRISE INTERNATIONAL LABS LTDROYAL PHARMA 2011 LIMITEDZETIRISEALBENDAZOLE200MG/5MLSUNRISE INTERNATIONAL LABS LTD, PLOT NO. 100, LANE-5, SECTOR-II, PHASE-II, IDA, CHERLAPALLY INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X10.0 ML BOTTLE22/03/2024
946NDA/MAL/HDP/11244LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDESOPRALINESOMEPRAZOLE MAGNESIUM TRIHYDRATE40MGLINCOLN PHARMACEUTICALS LTD, 10, 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
947NDA/MAL/HDP/11245LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDVALPIN-200SODIUM VALPROATE200MGLINCOLN PHARMACEUTICALS LTD, 10, 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
948NDA/MAL/HDP/11246SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD., ROYAL PHARMA 2011 LIMITEDSCOFIX 400CEFIXIME TRIHYDRATE400MGM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED, HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER22/03/2024
949NDA/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
950NDA/MAL/HDP/11249LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDARH-LARTEMETHER + LUMEFANTRINE(180 MG + 1080 MG)/ 60MLLINCOLN PHARMACEUTICALS LTD, 10, 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
951NDA/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 LTD, 8, PALGHAR TALUKA INDUSTRIAL CO - OPERATIVE ESTATE LIMITED PALGHAR, DISTRICT - PALGHAR, 401404INDIATOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE22/03/2024
952NDA/MAL/HDP/11252AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDTELMICLAR HTZ 40/12.5TELMISARTAN + HYDROCHLOROTHIAZIDE40 MG + 12.5 MGAJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER16/03/2024
953NDA/MAL/HDP/11253FRESENIUS KABI MANUFACTUING S.A. (PTY) LTD SURGIPHARM (U) LIMITEDCLINDAMYCIN FRESENIUS 600MG/4MLCLINDAMYCIN PHOSPHATE600MG/4MLFRESENIUS KABI MANUFACTURING SA (PTY) LIMITED, 6 GIBAUD ROAD, KORSTEN, 6020, PORT ELIZABETH, SOUTH AFRICA| LABESFAL LABORATORIOS ALMIRO, S.A , ZONA INDUSTRIAL DO LAGEDO, 3465-157 SANTIAGO DE BESTEIROS PORTUGAL| SOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X4.0 ML AMPOULE IN 5ML AMPOULE22/03/2024
954NDA/MAL/HDP/11254AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDORIXO 400OFLOXACIN400MGAJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER16/03/2024
955NDA/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
956NDA/MAL/HDP/11256BRAWN LABORATORIES LTDTATA UGANDA LIMITEDMOXIBRUMOXIFLOXACIN0.5% W/VBRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIAOPHTHALMIC DROPS 1.0X1.0X10.0 ML BOTTLE22/03/2024
957NDA/MAL/HDP/11257BRAWN LABORATORIES LTDTATA UGANDA LIMITEDBRUCOXIA-90ETORICOXIB90MGBRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
958NDA/MAL/HDP/11258AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDADERAN HTZ 16/12.5CANDESARTAN CILEXETIL + HYDROCHLOROTHIAZIDE16 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 BLISTER16/03/2024
959NDA/MAL/HDP/11259UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDMAGNILEKGADOPENTETATE DIMEGLUMINE469MG/MLUNIQUE PHARMACEUTICAL LABORATORIES, PLOT NO.4, PHASE IV, GIDC, INDUSTRIAL AREA, PANOLI- 394 116, DIST: BHARUCH, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL,1.0X15.0 ML VIAL,1.0X20.0 ML VIAL22/03/2024
960NDA/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
961NDA/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
962NDA/MAL/HDP/11262AMN LIFE SCIENCE PVT LTDVITACARE LIMITEDMOXITAM 125AMOXICILLIN TRIHYDRATE125MG PER 5MLAMN LIFE SCIENCE PVT LTD, 67/P-1, MALAV, AREA-BHILAD, VALSAD-396105, GUJARATINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X60.0 ML BOTTLE22/03/2024
963NDA/MAL/HDP/11263ORCHIDIA PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNORMOPROSTLATANOPROST50MCG/MLORCHIDIA PHARMACEUTICAL INDUSTRIES, AL OBOUR CITY INDUSTRIAL ZONE, AREA 14, 15 - PLOT NO. 12011 - CAIRO - EGYPTEGYPTOPHTHALMIC DROPS 1.0X1.0X3.0 ML BOTTLE22/03/2024
964NDA/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
965NDA/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
966NDA/MAL/HDP/11266I-CARE PHARMA LTDAIVEEN (U) LIMITEDIZ 500AZITHROMYCIN DIHYDRATE500MGCORONA REMEDIES PVT. LTD, VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER16/03/2024
967NDA/MAL/HDP/11267CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCACHMAX-200CEFIXIME TRIHYDRATE200 MGINNOVA CAPTAB PVT. LTD, 1281/1, 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
968NDA/MAL/HDP/11268DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDPARACO-DENK 1000/60PARACETAMOL + CODEINE PHOSPHATE HEMIHYDRATE1000 MG + 60 MGBENE-ARZNEIMITTEL GMBH, HERTERTICHSTR. 1-3, 81479 MUNCHEN - GERMANYGERMANYRECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP16/03/2024
969NDA/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
970NDA/MAL/HDP/11270RUSAN PHARMA LTD.NORVIK ENTERPRISES LIMITEDADDNOK-N 2/0.5BUPRENORPHINE HYDROCHLORIDE + NALOXONE HYDROCHLORIDE2 MG + 0.5 MGRUSAN PHARMA LTD, KHASRA NO. 122MI, CENTRAL HOPE TOWN, BEHIND PHARMA CITY, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY SUBLINGUAL TABLETS 1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER22/03/2024
971NDA/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
972NDA/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,1.0X90.0 TABLET BOTTLE,1.0X180.0 TABLET BOTTLE16/03/2024
973NDA/MAL/HDP/11274HILTON PHARMA (PVT) LTDBOOTS PHARMACEUTICALS LIMITEDDAPA 10MGDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE10 MGHILTON PHARMACEUTICALS (PVT) LIMITED, PLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER16/03/2024
974NDA/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
975NDA/MAL/HDP/11276CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDQUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE 400/300/300 MG TABLETEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE400MG + 300MG + 300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL), PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARK| CIPLA LIMITED, PLOT NO. A-33, A-2 & A-37/2/2 (UNIT-I), A-42(UNIT-II), MIDC PATALGANGA, 410220 DISTRICT RAIGAD, MAHARASHTRAUGANDA| INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER,1.0X90.0 TABLET CONTAINER16/03/2024
976NDA/MAL/HDP/11277SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDANGILOCK 50LOSARTAN POTASSIUM50 MGSQUARE PHARMACEUTICALS LIMITED - DHAKA UNIT, KALIAKOIR GAZIPURBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER16/03/2024
977NDA/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
978NDA/MAL/HDP/11279MSN LABORATORIES PRIVATE LIMITED,METRO PHARMACEUTICALS 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
979NDA/MAL/HDP/1128LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBTC KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GLINCOLN PHARMACEUTICALS L.T.D, TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY COMBINATION PACK TABLETS 1.0X4.0 TABLET BLISTER01/07/2013
980NDA/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
981NDA/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
982NDA/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
983NDA/MAL/HDP/11283THE SEARLE COMPANY LIMITEDSURGIPHARM (U) LIMITEDVAPTOR 10MGROSUVASTATIN CALCIUM10MGSEARLE PAKISTAN LIMITED,, F-319, SITE KARACHIPAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER16/03/2024
984NDA/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
985NDA/MAL/HDP/11285JSC BIOCAD, SAINT PETERSBURGONCOPHARM (U) LTDBEVALASTBEVACIZUMAB25 MG/MLJSC BIOCAD NEUDORF, FACILITY 2, BLD. 38, CONSTRUCTION 1, SVYAZI ST., STRELNA, SAINT-PETERSBURG, RUSSIA, 198515RUSSIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X1.0X4.0 ML VIAL,1.0X1.0X16.0 ML VIAL22/03/2024
986NDA/MAL/HDP/11286JSC BIOCADONCOPHARM (U) LTDACELLBIARITUXIMAB10 MG/MLJSC BIOCAD NEUDORF, FACILITY 2, BLD. 38, CONSTRUCTION 1, SVYAZI ST., STRELNA, SAINT-PETERSBURG, RUSSIA, 198515RUSSIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X1.0X50.0 ML VIAL22/03/2024
987NDA/MAL/HDP/11287LABORATÓRIOS BASIONCOPHARM (U) LTDMIDAZOLAM BASIMIDAZOLAM15 MG/3 MLLABORATORIOS BASI - INDUSTRIA FARMACEUTICA, PARQUE INDUSTRIAL MANUEL LOURENCO FERREIRA, LOTES 8, 15 E 16, 3450-232 MORTAGUA - PORTUGALPORTUGALPARENTERAL ORDINARY AMPOULES 1.0X10.0X3.0 ML AMPOULE22/03/2024
988NDA/MAL/HDP/11288MICRO LABS LIMITEDPHARMA VILLE LIMITEDPARACETAMOL BP 500MG TABLETPARACETAMOL 500MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER22/03/2024
989NDA/MAL/HDP/11289MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDADCCLENA 5LENALIDOMIDE5MGMYLAN LABORATORIES LTD, PLOT 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
990NDA/MAL/HDP/11290MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDADCCLENA 10LENALIDOMIDE10MGMYLAN LABORATORIES LTD, PLOT 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
991NDA/MAL/HDP/11291MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDADCCLENA 15LENALIDOMIDE15MGMYLAN LABORATORIES LTD, PLOT 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
992NDA/MAL/HDP/11292HEALTHCARE PHARMACEUTICALS LTDMIDAS CARE (U) LIMITEDCANDINILFLUCONAZOLE50 MG/5MLHEALTHCARE PHARMACEUTICAL LIMITEDGAZARIAPARA, RAJENDRAPUR, GAZIPUR 1703 - BANGLADESHINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X35.0 ML BOTTLE01/07/2002
993NDA/MAL/HDP/11293PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMOFECON 500MYCOPHENOLATE MOFETIL500MGCONCORD BIOTECH LIMITED, 297-298/2P, AT. VALTHERA, TAL - DHOLKA, DIST - AHMEDABAD - 382225, GUJARAT - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0X10.0 TABLET BLISTER22/03/2024
994NDA/MAL/HDP/11294PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMOFECON C-250MYCOPHENOLATE MOFETIL250 MGCONCORD BIOTECH LIMITED, 297-298/2P, AT. VALTHERA, TAL - DHOLKA, DIST - AHMEDABAD - 382225, GUJARAT - INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X6.0X10.0 CAPSULE BLISTER22/03/2024
995NDA/MAL/HDP/11295PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDYGLI €“ 100SITAGLIPTIN100MGBAFNA PHARMACEUTICALS LIMITED UNIT II, NO. 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
996NDA/MAL/HDP/11296PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDYGLI-50SITAGLIPTIN50MGBAFNA PHARMACEUTICALS LIMITED UNIT II, NO. 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
997NDA/MAL/HDP/11297MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-AMOLMESARTAN MEDOXOMIL + AMLODIPINE BESILATE40MG + 5MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
998NDA/MAL/HDP/11298MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-AMOLMESARTAN MEDOXOMIL + AMLODIPINE BESILATE20MG + 5MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
999NDA/MAL/HDP/11299LABORATÓRIOS VITÓRIA, S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRAUSANCITICOLINE SODIUM100MG/MLFAES FARMA SA, MAXIMO AGUIRRE 14. 48940 LEIOA €“ SPAINSPAINORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X50.0 ML BOTTLE22/03/2024
1000NDA/MAL/HDP/1130LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDKLARO-500CLARITHROMYCIN TABLETS 500MGLINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2012
1001NDA/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 - INDIA| SOFARIMEX INDUSTRIA QUIMIRA E FARMACEUTICA SA, AV. DAS INDUSTRIAS - ALTO DO COLARIDE, 2735-213, CACEM - PORTUGALINDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL28/03/2024
1002NDA/MAL/HDP/1132STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDM-CALZCALCIUM CITRATE +MAGNESIUM HYDROXIDE + ZINC SULPHATE + COLECALCIFEROL1000MG+100MG+4MG+200.I.USTEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP01/07/2012
1003NDA/MAL/HDP/11329AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDGLIMERON 4GLIMEPIRIDE 4MGAJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER22/05/2024
1004NDA/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, INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER24/05/2024
1005NDA/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, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0X1.0 TABLET BLISTER22/05/2024
1006NDA/MAL/HDP/11332WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ŏ.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, TURKEYTURKEYORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE24/05/2024
1007NDA/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,INDIAINDIANASAL SYSTEMIC DROPS 1.0X1.0X20.0 ML BOTTLE22/05/2024
1008NDA/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,INDIAINDIANASAL SYSTEMIC DROPS 1.0X1.0X10.0 ML BOTTLE24/05/2024
1009NDA/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,INDIAINDIANASAL SYSTEMIC DROPS 1.0X1.0X10.0 ML BOTTLE22/05/2024
1010NDA/MAL/HDP/11336MICRO LABS LIMITEDLABOREX UGANDA LIMITEDTOLSIN 0.4TAMSULOSIN HYDROCHLORIDE0.4 MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER22/05/2024
1011NDA/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 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE24/05/2024
1012NDA/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, INDIAINDIATOPICAL EXTERNAL PRESSURISED AEROSOLS 1.0X55.0 G CANNISTER24/05/2024
1013NDA/MAL/HDP/11339ZUVENTUS HEALTHCARE LIMITEDNORVIK ENTERPRISES LIMITEDCORTIMAX 6 MGDEFLAZACORT6 MGM/S ZUVENTUS HEALTHCARE LIMITED, KAMEREY BHASMEY, ELAKA PAKYONG, RANGPO, EAST SIKKIM, 737132 - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X6.0 TABLET BLISTER11/06/2024
1014NDA/MAL/HDP/11340ZUVENTUS HEALTHCARE LIMITEDNORVIK ENTERPRISES LIMITEDCORTIMAX 12MGDEFLAZACORT12 MGM/S ZUVENTUS HEALTHCARE LIMITED, KAMEREY BHASMEY, ELAKA PAKYONG, RANGPO, EAST SIKKIM, 737132 - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X6.0 TABLET BLISTER11/06/2024
1015NDA/MAL/HDP/11341PUNISKA HEALTHCARE PRIVATE LIMITEDNORVIK ENTERPRISES LIMITEDAEPISETEMLEVETIRACETAM100 MG/MLPUNISKA HEALTHCARE PRIVATE LIMITED, SURVEY NO. 168/1/1, PIPAN, SANAND, DISTRICT - AHMEDABAD 380053, GUJARAT - INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X2.0X5.0 ML VIAL11/06/2024
1016NDA/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 INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER22/05/2024
1017NDA/MAL/HDP/11343SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDANGILOCK 25LOSARTAN POTASSIUM25MGSQUARE PHARMACEUTICALS LIMITED - DHAKA UNIT, KALIAKOIR GAZIPURINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER01/06/2024
1018NDA/MAL/HDP/11344WOCKHARDT LTDKAMCARE PHARMA LIMITEDZEDEX 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 - INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/06/2024
1019NDA/MAL/HDP/11345WOCKHARDT LTDKAMCARE PHARMA LIMITEDZEDEX 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 - INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X25.0X4.0 CAPSULE BLISTER01/06/2024
1020NDA/MAL/HDP/11346MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTORSINEX-10TORSEMIDE10MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1021NDA/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 396195INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X20.0 ML VIAL01/06/2024
1022NDA/MAL/HDP/11348ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDOTRINALXYLOMETAZOLINE HYDROCHLORIDE0.1%W/VABACUS PARENTERAL DRUGS LIMITED, PLOT 114, BLOCK 191, KINGAUGANDANASAL TOPICAL DROPS 1.0X1.0X10.0 ML VIAL01/06/2024
1023NDA/MAL/HDP/11349VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDZINAVIR 750 MGCEFUROXIME SODIUM750MGINJECT CARE PARENTERALS PVT LTD, PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X10.0 ML VIAL + 1*1*10ML WFI IN LDPE BOTTLE01/06/2024
1024NDA/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,INDIAINDIAVAGINAL TABLETS 1.0X1.0X6.0 PESSARY STRIP01/06/2024
1025NDA/MAL/HDP/11351AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDLOTELLOTEPREDNOL ETABONATE0.5%W/WAJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAOPHTHALMIC GELS/SOLS 1.0X1.0X5.0 ML BOTTLE22/05/2024
1026NDA/MAL/HDP/11352AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDBRINZOXBRINZOLAMIDE1.0% W/VAJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAOPHTHALMIC SUSPENSIONS 1.0X1.0X5.0 ML BOTTLE22/05/2024
1027NDA/MAL/HDP/11353AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDBETOACTBEPOTASTINE BESILATE1.5% W/VAJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE22/05/2024
1028NDA/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
1029NDA/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 INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X40.0 CAPSULE CONTAINER22/05/2024
1030NDA/MAL/HDP/11357MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDDOVPRELAPRETOMANID200MGMYLAN LABORATORIES LIMITED, NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X26.0 TABLET CONTAINER24/05/2024
1031NDA/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, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER24/05/2024
1032NDA/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) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER22/05/2024
1033NDA/MAL/HDP/1136GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSCAB APPLICATIONBENZYL BENZOATE25%W/WAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL EMULSIONS 1.0X1.0X100.0 ML BOTTLE01/07/2013
1034NDA/MAL/HDP/11360ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDHALOSCOT 10HALOPERIDOL10MGM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED, HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER22/05/2024
1035NDA/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)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER24/05/2024
1036NDA/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)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER24/05/2024
1037NDA/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)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER24/05/2024
1038NDA/MAL/HDP/11364ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDDESLOSCOT-5DESLORATADINE5MGM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED, HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER24/05/2024
1039NDA/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 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER,1.0X90.0 TABLET CONTAINER24/05/2024
1040NDA/MAL/HDP/11366ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDSCOZINC-20 DTZINC SULPHATE MONOHYDRATE20MGM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED, HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER24/05/2024
1041NDA/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, 500101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/05/2024
1042NDA/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 PALESTINEPALESTINEVAGINAL SUPPOSITORIES 1.0X1.0X3.0 OVULE BLISTER22/05/2024
1043NDA/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, SWITZERLANDSWITZERLANDPARENTERAL ORDINARY VIALS 1.0X1.0X1.0 ML VIAL + 1*1 FILTER NEEDLE22/05/2024
1044NDA/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, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X15.0 ML VIAL22/05/2024
1045NDA/MAL/HDP/11376UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDUNIFEN 10BACLOFEN10 MGUNICHEM LABORATORIES LTD, UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER24/05/2024
1046NDA/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 INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/06/2024
1047NDA/MAL/HDP/11378UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDUNIFEN 20BACLOFEN20MGUNICHEM LABORATORIES LTD, UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER24/05/2024
1048NDA/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 1.0X60.0 TABLET BOTTLE01/06/2024
1049NDA/MAL/HDP/1138GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-CALAMINECALAMINE15%W/WAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL LOTIONS 1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/2013
1050NDA/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 - EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER01/06/2024
1051NDA/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
1052NDA/MAL/HDP/11383MICRO LABS LIMITEDLABOREX UGANDA LIMITEDMETAPIR 100TOPIRAMATE100MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1053NDA/MAL/HDP/11385BETA DRUGS LTDPHARMACINE UGANDA LIMITEDADCARB 450MG/45MLCARBOPLATIN10 MG/MLBETA DRUGS LIMITED, KHURUNI-LOHIMAJRA ROAD THE: BADDI, DISTT: SOLAN (H.P) - INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0X45.0 ML VIAL22/05/2024
1054NDA/MAL/HDP/11386MICRO LABS LIMITEDLABOREX UGANDA LIMITEDMETAPIR - 50TOPIRAMATE50MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1055NDA/MAL/HDP/11389OMNICALS PHARMA PVT. LTDGITTOES PHARMACEUTICALS LIMITEDOMIZINC 20ZINC SULFATE MONOHYDRATE20MGTHE ACME LABORATORIES LIMITED, DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESHINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER22/05/2024
1056NDA/MAL/HDP/1139GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE BETAMETHASONE0.1%W/WAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2013
1057NDA/MAL/HDP/11390BHARAT SERUMS & VACCINES LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPHONEXAMPHOTERICIN B50MGBHARAT SERUM AND VACCINES LIMITED, PLOT NO. K-27 ADDITIONAL M.I.D.C INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X50.0 MG VIAL01/06/2024
1058NDA/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
1059NDA/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
1060NDA/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
1061NDA/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-392130INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1062NDA/MAL/HDP/11397MDI PHARMA.WIDE SPECTRUM ENTERPRISES (U) LIMITEDVIASALMOLSALBUTAMOL SULPHATE0.1 MG/ACTUACTIONMDI PHARMA, PART NO. 14 €“ BLOCK 20016 WESTERN EXTENSION EL OBOUR CITY €“ EL KALYOUBIA, EGYPTEGYPTLUNG ADMINISTRATION METERED-DOSE INHALER 1.0X1.0X200.0 METERED DOSE CANNISTER30/07/2024
1063NDA/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
1064NDA/MAL/HDP/11399DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDDOLOGAN DENKPARACETAMOL + IBUPROFEN + CAFFEINE250 MG + 200 MG + 50 MGARTESAN PHARMA GMBH & CO. KG, WENDLANDSTR.1, 29439, LUCHOWGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER24/05/2024
1065NDA/MAL/HDP/1140GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE-NBETAMETHASONE+NEOMYCIN SULPHATE0.1%W/W+0.5%W/WAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2013
1066NDA/MAL/HDP/11400 ZIM LABORATORIES LTDREDDYS PHARMA LIMITEDCLARZIM 500CLARITHROMYCIN500MGZIM LABORATORIES LIMITED, B-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/06/2024
1067NDA/MAL/HDP/11401MICRO LABS LIMITEDLABOREX UGANDA LIMITEDARTESUNATE AMODIAQUINE BILAYER TABLETS 50MG/135MGARTESUNATE + AMODIAQUINE50MG+135MGMICRO LABS LTD,, PLOT S-155 TO S-159, VERNA IND. ESTATE, PHASE III, VERNA-GOA-403722INDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X25.0X3.0 TABLET BLISTER22/05/2024
1068NDA/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-403722INDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X25.0X3.0 TABLET BLISTER22/05/2024
1069NDA/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
1070NDA/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-403722INDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X25.0X3.0 TABLET BLISTER22/05/2024
1071NDA/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 - EGYPTEGYPTPARENTERAL ORDINARY VIALS 1.0X1.0X10.0 ML VIAL21/06/2024
1072NDA/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
1073NDA/MAL/HDP/11408MEDOCHEMIE LTD.LABOREX UGANDA LIMITEDCELMANTIN 20ROSUVASTATIN CALCIUM20MGMEDOCHEMIE (FACTORY AZ)., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOLCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1074NDA/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, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1075NDA/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 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER01/06/2024
1076NDA/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 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER01/06/2024
1077NDA/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 LIFE SCIENCES LTD., YONGJE-DONG IKSA-51, JEONBUK-DO 570350NORTH KOREAPARENTERAL ORDINARY VIALS 1.0X10.0X2.5 ML VIAL,1.0X10.0X0.5 ML VIAL24/05/2024
1078NDA/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 - INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X3.0 TABLET BLISTER24/05/2024
1079NDA/MAL/HDP/11414AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBSTYLE 5NEBIVOLOL HYDROCHLORIDE5MGAUROBINDO PHARMA LIMITED UNIT 3, PLOT NO. 313, 314, BACHUPALLY, RR DIST. 500090 INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER24/05/2024
1080NDA/MAL/HDP/11415NEXT WAVE (INDIA)REVITAL HEALTH CARE LTDMUPORIGMUPIROCIN2% W/WNEXT WAVE, RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P)INDIATOPICAL EXTERNAL OINTMENTS 1.0X1.0X10.0 G TUBE22/05/2024
1081NDA/MAL/HDP/11416BIODEAL LABORATORIES LTD PLOT NO.123ABACUS PHARMA (AFRICA) LIMITEDPODOSAL PAINTPODOPHYLLUM RESIN20%W/VBIODEAL LABOARATORIES LTD, 123, LUNGA LUNGA ROAD, INDUSTRIAL AREA, NAIROBIKENYATOPICAL EXTERNAL LIQUIDS 1.0X1.0X10.0 ML VIAL12/06/2024
1082NDA/MAL/HDP/11417 CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYTEL 80TELMISARTAN80MGEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1083NDA/MAL/HDP/11418FAROMED LIFESCIENCES LLPABACUS PHARMA (AFRICA) LIMITEDACORATICAGRELOR90 MGADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED, 7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER21/05/2024
1084NDA/MAL/HDP/11419FAROMED LIFESCIENCES LLPABACUS PHARMA (AFRICA) LIMITEDAPTINVILDAGLIPTIN50MGADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED, 7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400BANGLADESHORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER21/05/2024
1085NDA/MAL/HDP/1142GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCANDIZOL CLOTRIMAZOLE 1%W/WAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2013
1086NDA/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
1087NDA/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, INDIAINDIAPARENTERAL 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 INJECTION22/05/2024
1088NDA/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, GUJARATINDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER22/05/2024
1089NDA/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 G TUBE01/06/2024
1090NDA/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 - INDIAINDIAORAL LIQUID ORDINARY DROPS 1.0X50.0X4.0 ML VIAL22/05/2024
1091NDA/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, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1092NDA/MAL/HDP/11426GLAXOSMITHKLINE BIOLOGICALS S.A. UNITED HEALTHCARE DISTRIBUTORS LTDMOSQUIRIXRTS,S (PLASMODIUM FALCIPARUM AND HEPATITIS B ANTIGEN )25 MICROGRAMS OF RTS,S/DOSE (0.5 ML)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-EAUXBELGIUMPARENTERAL ORDINARY DRY VIALS 1.0X50.0X2.0 DOSE VIAL + 1*50*1ML GLASS VIAL OF DILUENT24/05/2024
1093NDA/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, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER01/06/2024
1094NDA/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, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1095NDA/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, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER01/06/2024
1096NDA/MAL/HDP/1143LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDLOSA-HLOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGLINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
1097NDA/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, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER01/06/2024
1098NDA/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-173205INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/06/2024
1099NDA/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-173205INDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE01/06/2024
1100NDA/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) - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/06/2024
1101NDA/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
1102NDA/MAL/HDP/11438MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOFLAMETOFENAMATE10% W/WMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X1.0X50.0 G TUBE01/06/2024
1103NDA/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, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/06/2024
1104NDA/MAL/HDP/11440MICRO LABS LIMITEDLABOREX UGANDA LIMITEDURYDOS-4SILODOSIN4 MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER01/06/2024
1105NDA/MAL/HDP/11441MICRO LABS LIMITEDLABOREX UGANDA LIMITEDURYDOS-8SILODOSIN8 MGMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER01/06/2024
1106NDA/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-74900PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER01/06/2024
1107NDA/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 - GIZAEGYPTORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER01/06/2024
1108NDA/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-74900PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER01/06/2024
1109NDA/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, GUJARATINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/06/2024
1110NDA/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 396195INDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X600.0 MG VIAL01/06/2024
1111NDA/MAL/HDP/11447FAROMED LIFESCIENCES LLPABACUS PHARMA (AFRICA) LIMITEDSITAP 100SITAGLIPTIN PHOSPHATE MONOHYDRATE100MGADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED, 7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER21/05/2024
1112NDA/MAL/HDP/11448ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDIBURO-200IBUPROFEN200MGSYNOKEM PHARMACEUTICALS LIMITED, SYNOKEM PHARMACEUTICALS LIMITED, PLOT NO. 35-36, SECTOR-6A, IIE, (SIDCUL), RANIPUR (BHEL), HARIDWAR, 249403, (UTTARAKHAND) - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/06/2024
1113NDA/MAL/HDP/11449PT SANBE FARMAMEDVIN PHARMA LIMITEDPUMPISELPANTOPRAZOLE SODIUM40 MG/VIALPT SANBE FARMA UNIT 3., JL INDUSTRI CIMAREME NO.8 PADALARANG 40533 BANDUNGINDONESIAPARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL01/06/2024
1114NDA/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) - INDIAINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER01/06/2024
1115NDA/MAL/HDP/11452ADWIAWIDE SPECTRUM ENTERPRISES (U) LIMITEDDANSET 4MG/2MLONDANSETRON HYDROCHLORIDE DIHYDRATE4MG/2MLADWIA S.A.E., 1ST INDUSTRIAL ZONE A1, 10TH OF RAMADAN CITY, EGYPTEGYPTPARENTERAL ORDINARY VIALS 1.0X1.0X3.0X2.0 ML VIAL,1.0X1.0X1.0X2.0 ML VIAL05/07/2024
1116NDA/MAL/HDP/11454COSMOS LTD.ASTRA PHARMA (U) LIMITEDHARTEZE 10RIVAROXABAN10MGCOSMOS LTD.., RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER31/05/2024
1117NDA/MAL/HDP/11455COSMOS LTD.ASTRA PHARMA (U) LIMITEDHARTEZE 15RIVAROXABAN15MGCOSMOS LTD.., RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER31/05/2024
1118NDA/MAL/HDP/11456COSMOS LTD.ASTRA PHARMA (U) LIMITEDHARTEZE 20RIVAROXABAN20MGCOSMOS LTD.., RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER31/05/2024
1119NDA/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 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1120NDA/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 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1121NDA/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, 500101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1122NDA/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, GUJARATINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/06/2024
1123NDA/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
1124NDA/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 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1125NDA/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-173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/06/2024
1126NDA/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 BOTTLE,1.0X100.0 ML BOTTLE01/06/2024
1127NDA/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 THAILANDTHAILANDORAL SOLID ORDINARY OTHER CAPSULES 1.0X30.0 CAPSULE CONTAINER,1.0X60.0 CAPSULE CONTAINER01/06/2024
1128NDA/MAL/HDP/11469LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDAZILEB-200AZITHROMYCIN DIHYDRATE200MG/5MLLEBEN LABORATORIES PVT LTD ., L-14 PHASE III MIDC AKOLA 444 104INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X15.0 ML BOTTLE31/07/2024
1129NDA/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, 500101INDIAORAL SOLID RETARD OTHER CAPSULES 1.0X3.0X7.0 CAPSULE BLISTER01/06/2024
1130NDA/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, 500101INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X7.0 CAPSULE BLISTER01/06/2024
1131NDA/MAL/HDP/11472LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDKIKVERMMEBENDAZOLE100MG/5MLLEBEN LABORATORIES PVT LTD ., L-14 PHASE III MIDC AKOLA 444 104INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X30.0 ML BOTTLE30/07/2024
1132NDA/MAL/HDP/11473MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCOROLORTICAGRELOR90 MGMICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1133NDA/MAL/HDP/11474LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDALWOALBENDAZOLE100MG/5MLLEBEN LABORATORIES PVT LTD ., L-14 PHASE III MIDC AKOLA 444 104INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X20.0 ML BOTTLE23/07/2024
1134NDA/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 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X15.0 TABLET BLISTER01/06/2024
1135NDA/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
1136NDA/MAL/HDP/11477BRAWN LABORATORIES LTDTATA UGANDA LIMITEDBUCLAPOXIME 200CEFPODOXIME PROXETIL200MGBRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/06/2024
1137NDA/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
1138NDA/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
1139NDA/MAL/HDP/11480MICRO LABS LIMITEDLABOREX UGANDA LIMITEDMOMESONEMOMETASONE FUROATE0.1% W/WMICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE01/06/2024
1140NDA/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
1141NDA/MAL/HDP/11482ARCELIA LIFE SCIENCES LTD.PLUTO PHARMACEUTICALS LIMITEDARCELIA® CEFIXIMECEFIXIME200 MGASSOCIATED BIOTECH, VILLAGE: KISHANPURA, GUGUMAJRA ROAD, BADDI THE: NALAGARH HIMACHAL PRADESH 174101 - INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X10.0 TABLET BLISTER01/06/2024
1142NDA/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
1143NDA/MAL/HDP/11484ACINO AGLABOREX UGANDA LIMITEDVICORDIA 5 MGIVABRADINE HYDROCHLORIDE5MGPHARMATHEN INTERNATIONAL S.A, INDUSTRIAL PARK SAPES, RODOPI PREFECTURE, BLOCK NO. 5, RODOPI 69300 - GREECEGREECEORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER01/06/2024
1144NDA/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, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/06/2024
1145NDA/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, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE01/06/2024
1146NDA/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
1147NDA/MAL/HDP/11490ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDFINRIVFINASTERIDE5 MGEAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1148NDA/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) INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL (10 ML AMBER GLASS VIAL) + 1*10 ML AMPOULE, WFI IN LDPE BOTTLE01/06/2024
1149NDA/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) INDIACHINAPARENTERAL ORDINARY VIALS 1.0X1.0X2.0 ML VIAL01/06/2024
1150NDA/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) INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X10.0X1.0 ML AMPOULE01/06/2024
1151NDA/MAL/HDP/11496SWISS PARENTERALS LTDSHREEJI CARE LIMITEDPHYLLINEAMINOPHYLLINE250MG/10MLSWISS PARENTERALS LIMITED (UNIT-1), 808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X10.0ML AMPOULE, 1.0X1.0X10.0X10.0ML AMPOULE, 22/05/2024
1152NDA/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 - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1153NDA/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, GUJARATINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X60.0 ML CONTAINER,1.0X1.0X100.0 ML CONTAINER01/06/2024
1154NDA/MAL/HDP/11499BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDARMENATE-60ARTESUNATE60MG/VIALINDASI LIFESCIENCE PRIVATE LIMITED, PLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN - 396210, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X60.0 MG VIAL 0.5ML VIALOF 5.0%W/V SODIUM CARBONATE + 2.5ML VIAL OF 0.9%W/V SODIUM CHLORIDE05/06/2024
1155NDA/MAL/HDP/1154 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDBACQUREIMIPENEM + CILASTATIN500MG + 500MGSUN PHARMACEUTICAL INDUSTRIES LIMITED, INDUSTRIAL AREA NO.3, A.B. ROAD DEWAS, 455001 (MP), INDIA.

INDIAPARENTERAL ORDINARY DRY VIALS 1.0X30.0 ML VIAL01/07/2012
1156NDA/MAL/HDP/1155TRIVENI FORMULATIONS LIMITEDSUPER MEDIC LTDDOXYCYCLINEDOXYCYCLINE 100TRIVENI FORMULATION LTD-PLOT NO.52,53,54,63,62,64, ALEAP INDUSTRIAL ESTATE SURAMPALI,
AP-INDIA – 521212
| 		INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2012
1157NDA/MAL/HDP/11574ALTHEA PHARMA PVT LTD.JOINT MEDICAL STORE (UPMB - UCMB)GLUCOSE INTRAVENOUS INFUSION BP 5 % W/VANHYDROUS GLUCOSE5.0%W/VALTHEA PHARMA PRIVATE LIMITED-WORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X500.0 ML BOTTLE04/11/2024
1158NDA/MAL/HDP/11577MSN PHARMACHEM PRIVITE LIMITEDMETRO PHARMACEUTICALS LIMITEDBREATHEZY 10MONTELUKAST10MGMSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION-PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER04/11/2024
1159NDA/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.P | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2012
1160NDA/MAL/HDP/11581AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDSINOCORTMOMETASONE FUMARATE0.05%W/WAMMAN PHARMACEUTICALS INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE, SAHAB, AMMAN | JORDAN | NASAL TOPICAL PRESSURISED AEROSOLS 1.0X1.0X120.0 METERED DOSE BOTTLE03/11/2024
1161NDA/MAL/HDP/11582FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDECOSPRIN PLUSASPIRIN + CLOPIDOGREL BISULFATE75 MG + 75 MGTHE ACME LABORATORIES LIMITED-DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER03/11/2024
1162NDA/MAL/HDP/11583MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCELEBIB 100CELECOXIB100 MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER03/11/2024
1163NDA/MAL/HDP/11584 CIPLA LTDQUALITY CHEMICAL INDUSTRIES LIMITEDFOSFOMAXFOSFOMYCIN TROMETAMOL3G/SACHETNEUTEC ILAC SAN. TIC. A.S.-1. OSB. 1. YOL NO: 3 VE 2. YOL, NO:2, ARIFIYE, SAKARYA/TURKEY | TURKEY | ORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X1.0X3.0 G SACHET03/11/2024
1164NDA/MAL/HDP/11585PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDYMET - 1000METFORMIN HYDROCHLORIDE1000 MGBAFNA PHARMACEUTICALS LIMITED UNIT II-NO. 147, MADHAVARAM RED HILLS ROAD, GRANTLYON VILLAGE, VADAKARAI POST, CHENNAI, TAMIL NADU - INDIA | INDIA | ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER03/11/2024
1165NDA/MAL/HDP/11588LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDCARVILIN-6.25CARVEDILOL6.25 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 1.0X2.0X14.0 TABLET BLISTER03/11/2024
1166NDA/MAL/HDP/11589LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDCARVILIN 12.5CARVEDILOL12.5 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 1.0X2.0X14.0 TABLET BLISTER03/11/2024
1167NDA/MAL/HDP/11593M/S SCOTT EDIL PHARMACIA LTDROYAL PHARMA 2011 LIMITEDALPA-DROCORTILPREDNISOLONE ACETATE1% W/VM/S SCOTT-EDIL PHARMACIA LTD -56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | OPHTHALMIC SUSPENSIONS 1.0X1.0X5.0 ML CONTAINER04/11/2024
1168NDA/MAL/HDP/11594PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDBORTETRUST 3.5BORTEZOMIB3.5 MG/VIALPANACEA BIOTEC PHARMA LIMITED-MALPUR, BADDI, DIST. SOLAN, HIMACHAL PRADESH, 173205 - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0X3.5 MG VIAL04/11/2024
1169NDA/MAL/HDP/11595ZENTA HEALTHCARE PVT. LTD. LEGIT MEDEQ 2007 LIMITEDBEXIDINPOVIDONE-IODINE + METRONIDAZOLE5% W/W + 1% W/WNANZ MED SCIENCE PHARMA PVT. LTD-RAMPUR GHAT, PAONTA SAHIB, DISTRICT SIRMOUR-173025, HIMACHAL PRADESH, INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X15.0 G TUBE04/11/2024
1170NDA/MAL/HDP/11596PLANET PHARMACEUTICALS UGANDA LTDPLANET PHARMACEUTICALS UGANDA LTDLUMENARARTEMETHER + LUMEFANTRINE20 MG + 120 MGFREDUN PHARMACEUTICALS LIMITED,-14,15,16 - ZORABIAN INDUSTRIAL COMPLEX, VEOOR, PALGHAR (E), THANE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER03/11/2024
1171NDA/MAL/HDP/11597RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDIBUREN-400IBUPROFEN400MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER03/11/2024
1172NDA/MAL/HDP/11598BAROQUE PHARMACEUTICALS PVT LTDJEET PHARMACEUTICALS LIMITEDBENISAR HLOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50 MG + 12.5 MGBAROQUE PHARMACEUTICALS PRIVATE LIMITED-192/2 & 3, 190/1 AND 202/9, AT. SOKHADA - 388620, TA.: KHAMBHAT DIST. ANAND, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER03/11/2024
1173NDA/MAL/HDP/11599KESAR PHARMAABACUS PHARMA (AFRICA) LIMITEDKESLEVOLEVOFLOXACIN HEMIHYDRATE750 MGKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER03/11/2024
1174NDA/MAL/HDP/11600AMN LIFE SCIENCE PVT LTDVITACARE LIMITEDMOXITAM 500AMOXICILLIN TRIHYDRATE500 MGAMN LIFE SCIENCE PVT LTD-67/P-1, MALAV, AREA-BHILAD, VALSAD-396105, GUJARAT | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER03/11/2024
1175NDA/MAL/HDP/11601AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDORIXO 200OFLOXACIN200 MGAJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER03/11/2024
1176NDA/MAL/HDP/11602AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDROSUCHOL-20ROSUVASTATIN CALCIUM20MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER03/11/2024
1177NDA/MAL/HDP/11605ARCELIA LIFE SCIENCES LTD.NOVOMED HEALTHCARE LIMITEDARCELIA IRON SUCROSE INJECTION BPELEMENTAL IRON20 MG/MLSANJAR PHARMA LLP-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X5.0 ML AMPOULE03/11/2024
1178NDA/MAL/HDP/11606AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDACTINAC ER 200ACECLOFENAC200 MGAJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER03/11/2024
1179NDA/MAL/HDP/11607AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDFEBURIC 40FEBUXOSTAT40 MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER03/11/2024
1180NDA/MAL/HDP/11609JERUSALEM PHARMACEUTICALS CO. LIMITEDGAMA PHARMACEUTICALS (U) LIMITEDAMECANEAMIKACIN SULFATE250MG/MLJERUSALEM PHARMACEUTICALS CO. LTD-AL-BIREH RAMALLAH INDUSTRIAL ZONE, AL-BIREH NABLUS ROAD, P.O. BOX: 3570 PALESTINE | PALESTINE | PARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X2.0 ML AMPOULE03/11/2024
1181NDA/MAL/HDP/11612CENTAUR PHARMACEUTICALS PVT. LTD.GITTOES PHARMACEUTICALS LIMITEDWOXHEALDIPEROXOCHLORIC ACID1.16 MG/ML BEFORE RECONSTITUTION 0.29 MG/ML AFTER RECONSTITUTIONCENTAUR PHARMACEUTICALS PVT. LTD (PLANT 1)-PLOT 3,5B, 2C TIVIM INDUSTRIAL ESTATE, KARASVADA, MAPUSA, GOA 403526 | INDIA | TOPICAL EXTERNAL LIQUIDS 1.0X1.0X7.5 ML CONTAINER + 1*22.5 ML, SODIUM CHLORIDE PACKED IN HDPE CONTAINER CO-PACKED WITH GAUZE03/11/2024
1182NDA/MAL/HDP/11616PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDTOFF-DCDEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE + PHENYLEPHRINE HYDROCHLORIDE10 MG + 2 MG + 5 MGPANACEA BIOTEC PHARMA LIMITED-MALPUR, BADDI, DIST. SOLAN, HIMACHAL PRADESH, 173205 - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER03/11/2024
1183NDA/MAL/HDP/11617NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDMECOFARMETFORMIN HYDROCHLORIDE500 MGNEXT WAVE-RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER03/11/2024
1184NDA/MAL/HDP/11621LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDMOLEBENMONTELUKAST SODIUM + LEVOCETRIZINE DIHYDROCHLORIDE10 MG + 5 MGLEBEN LABORATORIES PRIVATE LIMITED-PLOT NO. L-4 & L-15, PHASE-III, MIDC, AKOLA-444 104 (MS). - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X1.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER03/11/2024
1185NDA/MAL/HDP/11622PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTACROCORD 1TACROLIMUS1 MGCONCORD BIOTECH LIMITED-297-298/2P, AT. VALTHERA, TAL - DHOLKA, DIST - AHMEDABAD - 382225, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X6.0X10.0 CAPSULE BLISTER03/11/2024
1186NDA/MAL/HDP/11623PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTACROCORD 5TACROLIMUS5 MGCONCORD BIOTECH LIMITED-297-298/2P, AT. VALTHERA, TAL - DHOLKA, DIST - AHMEDABAD - 382225, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X6.0X10.0 CAPSULE BLISTER03/11/2024
1187NDA/MAL/HDP/11624PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTACROCORD 0.5TACROLIMUS0.5MGCONCORD BIOTECH LIMITED-297-298/2P, AT. VALTHERA, TAL - DHOLKA, DIST - AHMEDABAD - 382225, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X6.0X10.0 CAPSULE BLISTER03/11/2024
1188NDA/MAL/HDP/11627BROOKES PHARMA (PRIVATE) LIMITEDHARLEYS UGANDA LIMITEDPRECIDEXDEXMEDETOMIDINE HYDROCHLORIDE100 MCG/MLBROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | PARENTERAL ORDINARY INFUSION AMPOULES 1.0X1.0X2.0X2.0 ML AMPOULE03/11/2024
1189NDA/MAL/HDP/11629M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDHENKA 60DULOXETINE HYDROCHLORIDE60 MGHETERO LABS LIMITED (UNIT I)-VILLAGE KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, PIN CODE 173205 | INDIA | ORAL SOLID RETARD CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER25/10/2024
1190NDA/MAL/HDP/1163SHOSAAN ASIC PACIFICRENE PHARMACY LTDFRUSEMIDE FUROSEMIDE40MGNEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATEINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
1191NDA/MAL/HDP/11630ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDLACONLACTULOSE3.39G/5MLM/S SCOTT-EDIL PHARMACIA LTD -56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X120.0 ML BOTTLE03/11/2024
1192NDA/MAL/HDP/11632M/S SCOTT EDIL PHARMACIA LTDROYAL PHARMA 2011 LIMITEDVOLIGESIC-75DICLOFENAC SODIUM25 MG/MLM/S SCOTT-EDIL PHARMACIA LTD -56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED-HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X10.0X3.0 ML AMPOULE03/11/2024
1193NDA/MAL/HDP/11636CIRON DRUGS AND PHARMACEUTICALS PVT LTDROYAL PHARMA 2011 LIMITEDTRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION USPTRIAMCINOLONE ACETONIDE40 MG/ MLCIRON DRUGS AND PHARMACEUTICALS PVT LTD .-N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, MAHARASHTRA STATE | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X1.0X2.0 ML AMPOULE03/11/2024
1194NDA/MAL/HDP/11639LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDNEVOSPRINNEOMYCIN SULFATE + POLYMYXIN B + SULFATE BACITRACIN ZINC(5 MG + 5000 UNITS + 400 UNITS)/GLINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X30.0 G TUBE03/11/2024
1195NDA/MAL/HDP/1164TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDPIROXICAMPIROXICAM20MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
1196NDA/MAL/HDP/11640ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDMOXVID-250AMOXICILLIN TRIHYDRATE250 MG/5MLM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED-HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE03/11/2024
1197NDA/MAL/HDP/1166PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDDOLZEROTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MGPANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
1198NDA/MAL/HDP/1167CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDMETOCLOPRAMIDE INJECTIONMETOCLOPRAMIDE5MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD ., N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA.INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE01/07/2010
1199NDA/MAL/HDP/1168DAWA LIMITEDSUPER MEDIC LTDDAWA-CORT CREAMHYDROCORTISONE1%W/WDAWA LTD , BABA DOGO ROAD, RUARAKA P.O.BOX 16633-00620, NAIROBI KENYAKENYATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2009
1200NDA/MAL/HDP/1169ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDNEBI 5NEBIVOLOL HYDROCHLORIDE 5MGARISTO PHARMACEUTCALS PVT LTD, PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X3.0X10.0 TABLET BLISTER01/07/2013
1201NDA/MAL/HDP/11691UNIZA LIFECARE PRIVATE LIMITEDJEET PHARMACEUTICALS LIMITEDUNIACEPARACETAMOL + ACECLOFENAC500MG + 100MGASSOCIATED BIOTECH-VILLAGE: KISHANPURA, GUGUMAJRA ROAD, BADDI THE: NALAGARH HIMACHAL PRADESH 174101 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER22/10/2024
1202NDA/MAL/HDP/1172CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE 20MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD ., N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA.INDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL,1.0X30.0 ML VIAL01/07/2010
1203NDA/MAL/HDP/1176AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFUNGISAFETERBINAFINE HYDROCHLORIDE1%W/WAMOUN PHARMACEUTICAL CO. S.A.E, 1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY,
KALYOUBIA CAIRO EGYPT
EGYPTTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2013
1204NDA/MAL/HDP/1178HETERO DRUGS LTDAIVEEN (U) LIMITEDTENOFOVIRTENOFOVIR DISOPROXIL FUMARATE300MGHETERO LABS LTD, 22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2013
1205NDA/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)SWITZERLANDPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 PREFILLED SYRINGE CARTON01/07/2015
1206NDA/MAL/HDP/1184DAWA LIMITEDSUPER MEDIC LTDDACOF MUCOLYTICSALBUTAMOL + BROMHEXINE + GUAIPHENESIN + MENTHOL2.0MG + 4.0MG +100MG + 1.0MGDAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2013
1207NDA/MAL/HDP/1185DAWA LIMITEDSUPER MEDIC LTDDACOF DRYDIPHENHYDRAMINE + DEXTROMETHORPHAN + MENTHOL12.5MG + 6.5MG + 1.10MGDAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2013
1208NDA/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 NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2013
1209NDA/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 | CHINAPARENTERAL ORDINARY AMPOULES 1.0X100.0X2.0 ML AMPOULE02/09/2019
1210NDA/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 | CHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X3.0 ML AMPOULE27/08/2019
1211NDA/MAL/HDP/1198THEMIS MEDICARE LTD.STAR PHARMACEUTICALS LTDMALITHER INJECTIONARTEMETHER80MG/MLTHEMIS MEDICARE LTD , SECTOR 6A ,PLOT NO. 16,17 & 18 IIE,BHEL SIDCUL,HARIDWAR UTTARAKHAND 249403INDIAPARENTERAL ORDINARY I M AMPOULES 1.0X6.0X1.0 ML AMPOULE01/07/2013
1212NDA/MAL/HDP/1199THEMIS MEDICARE LTDSTAR PHARMACEUTICALS LTDTHEMISET 75PALONOSETRON HYDROCHLORIDE0.075MG/1.5ML THEMIS MEDICARE LIMITED, SECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHANDINDIAPARENTERAL ORDINARY VIALS 1.0X1.5 ML VIAL01/07/2013
1213NDA/MAL/HDP/1201THEMIS MEDICARE LTDSTAR PHARMACEUTICALS LTDTHEMISETPALONOSETRON HYDROCHLORIDE0.25MG/5ML THEMIS MEDICARE LIMITED, SECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHANDINDIAPARENTERAL ORDINARY VIALS 1.0X5.0 ML VIAL01/07/2013
1214NDA/MAL/HDP/1204THEMIS MEDICARE LTDSTAR PHARMACEUTICALS LTDDEXEM INJECTIONDEXMEDETOMIDINE HYDROCHLORIDE 100THEMIS MEDICARE LTD, SECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHANDINDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE01/07/2013
1215NDA/MAL/HDP/1206THE METHOLATUM CO. LTDHARLEYS UGANDA LIMITEDDEEP RELIEFIBUPROFEN + MENTHOL5%W/W + 3% W/WTHE MENTHOLATUM CO. LTD. , 1 REDWOOD AVE PEEL PARK CAMPUS EAST KILBRIDEUNITED KINGDOMTOPICAL EXTERNAL OTHER GELS/SOLS 1.0X50.0 G CONTAINER,1.0X15.0 G CONTAINER,1.0X30.0 G CONTAINER01/07/2013
1216NDA/MAL/HDP/1208ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDVISCO LIQUIDALGINIC ACID + MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE + SIMETHICONE100 MG + 250 MG + 125 MG + 50 MGARISTO PHARMACEUTCALS PVT LTD, PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESHINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2011
1217NDA/MAL/HDP/1209MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-80TELMISARTAN80MGMICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2011
1218NDA/MAL/HDP/1211ASTRA ZENECA MACNAUGHTON LIMITEDBRILINTATICAGRELOR90MGASTRA ZENECA AB, SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)UNITED KINGDOMORAL SOLID ORDINARY TABLETS 1.0X4.0X14.0 TABLET BLISTER01/07/2011
1219NDA/MAL/HDP/1215BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGYNANFORT VAGINAL PESSARYMETRONIDAZOLE+NEOMYCIN SULPHATE+NYSTATIN500MG+65,000I.U+100,000I.UBLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAVAGINAL SUPPOSITORIES 1.0X10.0 TABLET BLISTER01/07/2013
1220NDA/MAL/HDP/1219DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDTORAS-DENK 5TORASEMIDE5MG DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
1221NDA/MAL/HDP/1220BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART ARTEMETHER + LUMEFANTRINE180 MG + 1080 MGBLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BLISTER01/07/2008
1222NDA/MAL/HDP/1223REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDWHITFIELD'S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WREGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS 1.0X1.0X25.0 G TUBE01/07/1997
1223NDA/MAL/HDP/1224ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDVAXCEL CEFTRIAXONECEFTRIAXONE1GKOTRA PHARMA SDN BDN, 1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIAMALAYSIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL01/07/2013
1224NDA/MAL/HDP/1227AMOUN PHARMACEUTICALS LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDFUNGISAFETERBINAFINE HCL250MGAMOUN PHARMACEUTICAL CO. S.A.E, 1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY,
KALYOUBIA CAIRO EGYPT
EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0 TABLET STRIP01/07/2013
1225NDA/MAL/HDP/1230MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDLOXAMPAMPICILLIN + CLOXACILLIN250 MG + 250 MGMEDOPHARM PVT LTD., NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
1226NDA/MAL/HDP/1231NORVIK ENTERPRISES LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 125AMOXYCILLIN125MG/5MLMEDOPHARM PVT LTD., NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2012
1227NDA/MAL/HDP/1232MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOCILLIN 125AMPICILLIN125 MGMEDOPHARM PVT LTD., NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2016
1228NDA/MAL/HDP/1244GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR SRLORNOXICAM16MGGLENMARK PHARMACEUTICALS LTD ., VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL BADDI, DISTRICT SOLAN HP 173205INDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
1229NDA/MAL/HDP/1247GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROCIPCYPROHEPTADINE4MGAGOG PHARMA LTD., PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X5.0X10.0 TABLET BLISTER01/07/2012
1230NDA/MAL/HDP/1252MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDZOYSILDENAFIL50MGTORQUE PHAMACEAUTICALS PVT LTD, VILL ISSAPUR P.O DAPPAR INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER01/07/2013
1231NDA/MAL/HDP/1254COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM TABLETSCO-TRIMOXAZOLE480MGCOSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER01/07/1998
1232NDA/MAL/HDP/1264CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUCYCLINE EYE OINTMENTTETRACYCLINE HYDROCHLORIDE1%W/WCENTAUR PHARMACEUTICALS PVT LTD -, PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIAOPHTHALMIC OINTMENTS 1.0X5.0 G TUBE,1.0X3.5 G TUBE01/07/2000
1233NDA/MAL/HDP/1265GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCOMBIPLEXVITAMIN B1 + VITAMIN B2 + NICOTINAMIDE + VITAMIN B61.0 MG + 1.0 MG + 15 MG + 0.5 MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2008
1234NDA/MAL/HDP/1275REMEDICA LTDGOODMAN INTERNATIONAL LTDNIFELAT 10 F.C TABLETSNIFEDIPINE10MGREMEDICA LIMITED , AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/1997
1235NDA/MAL/HDP/1278SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDTRIDEM PHARMA UGANDA LIMITEDD-ARTEPPDIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE40MG +320MGGUILIN PHARMACEUTICAL CO LTD, NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY TABLETS 1.0X9.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER,1.0X25.0X1.0X9.0 TABLET BLISTER01/07/2013
1236NDA/MAL/HDP/1291BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST-300 IOPROMIDE300MG/MLBAYER PHARMA A.G, MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL01/07/2012
1237NDA/MAL/HDP/1294BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST 370IOPROMIDE370MG/MLBAYER PHARMA A.G, MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL01/07/2012
1238NDA/MAL/HDP/1295SHAIGAN PHARMACEUTICALS (PVT) LTDHARLEYS UGANDA LIMITEDZEPARALBENDAZOLE200MGSHAIGAN PHARMACEUTICALS (PVT) LTD, 14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET BLISTER01/07/1997
1239NDA/MAL/HDP/1302CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDHIPEN CAPSULESAMOXYCILLIN250MGSPARSH BIO-TECH PVT. LIMITED, PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
1240NDA/MAL/HDP/1304MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE PLUS 2GLIMEPIRIDE+ METFORMIN2MG + 500MGMICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
1241NDA/MAL/HDP/1307MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL 40TELMISARTAN40MGMICRO LABS LTD .., 57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADUINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
1242NDA/MAL/HDP/1312 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM- 2.5DIAZEPAM2.5MGBLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES 1.0X5.0 SUPPOSITORY BLISTER01/07/2007
1243NDA/MAL/HDP/1319REMEDICA LTDGOODMAN INTERNATIONAL LTDZESTAVAL 200 F.C TABLETSALBENDAZOLE200MGREMEDICA LTD, AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOLCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 50.0X2.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER01/07/1997
1244NDA/MAL/HDP/1324MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDTOOTH HEALMULTI INGREDIENTMULTI INGREDIENTTORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X18.0 ML BOTTLE01/07/2005
1245NDA/MAL/HDP/1328GSK BIOLOGICALS SAUNITED HEALTHCARE DISTRIBUTORS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN20MCG/MLGLAXOSMITHKLINE BOILOGICALS, S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS 1.0X10.0X1.0 ML VIAL (1 DOSE),1.0X25.0X1.0 ML VIAL (1 DOSE)01/07/1997
1246NDA/MAL/HDP/1331ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM N OINTMENTBETAMETHASONE VALERATE + NEOMYCIN0.1%W/W + 0.5%W/WATCO LABORATORIES PVT LTD, B-18,S.I.T.E KARACHI 75700, PAKISTANPAKISTANTOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE,1.0X5.0 G TUBE01/07/1997
1247NDA/MAL/HDP/1335INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPREGATASPREGABALIN75MGINTAS PHARMACEUTICALS LTD, CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2012
1248NDA/MAL/HDP/1337FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFOURTS BTHIAMINE +RIBOFLAVIN + PYRIDOXINE + NICOTINAMIDE + FOLIC ACID + ASCORBIC ACID + COLECALCIFEROL + ACETYL CYSTEINE + GLYCINE + GLUTAMIC ACID + CHROMIUM + VANADIUM + ZINC + SELENIUM10MG + 10MG + 3MG + 50MG + 1MG + 75MG + 400IU + 25MG +25MG +MG +200MCG + 100MCG + 55MG +100MCGFOURRTS INDIA LABORATORIES PVT. LIMITED, VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2016
1249NDA/MAL/HDP/1338LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDGRISEBEN 500GRISEOFULVIN500 MGLEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2016
1250NDA/MAL/HDP/1342ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL CEPHALEXIN 250CEPHALEXIN MONOHYDRATE250MGKOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL SOLID ORDINARY CAPSULES 1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2008
1251NDA/MAL/HDP/1345ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDSWICH-200CEFPODOXIME200MG EAST AFRICAN (INDIA) OVERSEAS (PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIA)INDIAORAL SOLID ORDINARY TABLETS 1.0)X1.0X10.0 TABLET BLISTER01/07/2014
1252NDA/MAL/HDP/1347MICRO LABS LIMITEDLABOREX UGANDA LIMITEDORNILOXORNIDAZOLE + OFLOXACIN500MG + 200MGMICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/07/2010
1253NDA/MAL/HDP/1348TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 500SODIUM VALPROATE (CONTROLLED RELEASE)500MGTORRENT PHARMACEUTICAL LTD, AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2009
1254NDA/MAL/HDP/1352MEDLEY PHARMACEUTICALS LTDEUROPA HEALTHCARE (U) LTDPLATFREECLOPIDOGREL75MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
1255NDA/MAL/HDP/1353MEDLEY PHARMACEUTICALS LTDEUROPA HEALTHCARE (U) LTDKITPYLO - CLANSOPRAZOLE + TINIDAZOLE + CLARITHROMYCIN30MG +500MG + 250MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)01/07/2015
1256NDA/MAL/HDP/1355PIRAMAL HEALTHCARE LTDMEDIWORLD PHARMA AFRICA LTDSEVOFLURANESEVOFLURANE100% V/VPIRAMAL ENTERPRISES LTD, INDIA, DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESHINDIAOTHER SYSTEMIC LIQUID INHALATIONS 1.0X250.0 ML BOTTLE01/07/2010
1257NDA/MAL/HDP/1359KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENAC-100 SRDICLOFENAC SODIUM100MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD, PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID RETARD CAPSULES 1.0X10.0 CAPSULE BLISTER01/07/2016
1258NDA/MAL/HDP/1361SWISS PARENTERALS LTDSHREEJI PHARMACEUTICALS LIMITEDFALCI CAREARTESUNATE120MGSWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X30.0 MG VIAL + 1*5ML OF 0.9%W/V NACL AMPOULE + 1*1ML OF 5%W/V NAHCO3 AMPOULE03/06/2021
1259NDA/MAL/HDP/1362MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-1000AMOXICILLIN + CLAVULANATE875 MG + 125 MGMICRO LABS LIMITED , PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X6.0 TABLET STRIP01/07/2013
1260NDA/MAL/HDP/1367DAWA LIMITEDSUPER MEDIC LTDACEPAR ACECLOFENAC + PARACETAMOL100 MG + 500 MGDAWA LTD, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER01/07/2013
1261NDA/MAL/HDP/1368ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD5GLUCOSE5%W/VABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE01/07/2010
1262NDA/MAL/HDP/1370ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDSTERILIZED WATER FOR INJECTIONWATER FOR INJECTIONNEUTRALABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY AMPOULES 1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE,1.0X7.5 ML AMPOULE01/07/2010
1263NDA/MAL/HDP/1377OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDSUPER AMPWATER FOR INJECTIONN/AOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD, VILLAGE €“ VASANA €“ CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0 ML AMPOULE01/07/2014
1264NDA/MAL/HDP/1380KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDHYCORT CREAMHYDROCORTISONE1%W/WKAMPALA PHARMECEUTICALS INDUSTRIES LTD., PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X30.0 G TUBE01/07/1997
1265NDA/MAL/HDP/1382HOVID BERHADUNITED HEALTHCARE DISTRIBUTORS LTDINOX CAPSULESITRACONAZOLE100MGHOVID BHD, LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIAMALAYSIAORAL SOLID ORDINARY CAPSULES 1.0X7.0X4.0 CAPSULE BLISTER01/07/2012
1266NDA/MAL/HDP/1383HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDKETOFEN GELKETOPROFEN2.5%W/WHOVID BHD (IPOH SITE), 121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA MALAYSIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G CONTAINER01/07/2013
1267NDA/MAL/HDP/1384CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE AND ZIDOVUDINE TABLETS LAMIVUDINE + ZIDOVUDINE30MG + 60MGCIPLA LTD.- , PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X60.0 TABLET BOTTLE01/07/2013
1268NDA/MAL/HDP/1387INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDLAN-30LANSOPRAZOLE30MGINTAS PHARMACEUTICALS LTD, CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X5.0X10.0 CAPSULE STRIP01/07/2004
1269NDA/MAL/HDP/1390ASTRA ZENECAMACNAUGHTON LIMITEDCRESTORROSUVASTATIN CALCIUM5MGIPR PHARMACEUTICALS INC,, LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICOPUERTO RICOORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER01/07/2010
1270NDA/MAL/HDP/1392ASTRA ZENECA MACNAUGHTON LIMITEDZOLADEXGOSERELIN3.6MGASTRA ZENECA UK LIMITED, ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 PREFILLED SYRINGE CARTON01/07/1997
1271NDA/MAL/HDP/1395ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MG IVESOMEPRAZOLE40MG/5MLASTRA ZENECA-, KVARNBERGAGATAN12, SE-151 SODERTALIJESWEDENPARENTERAL ORDINARY VIALS 1.0X1.0X5.0 ML VIAL,1.0X10.0X5.0 ML VIAL01/07/2010
1272NDA/MAL/HDP/1397ASTRA ZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE10MGASTRAZENECA PHARMACEUTICAL CO LTD., NO. 2 HUANGSHAN ROAD, WUXI, 214028, JIANGSU| ASTRAZENECA SWEDEN OPERATIONS, ASTRAZENECA SWEDEN OPERATIONS SE-151 85 SODERTALJECHINA| SWEDENORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2001
1273NDA/MAL/HDP/1399CIPLA LTD.ABACUS PHARMA (AFRICA) LIMITEDASTHALIN SALBUTAMOL100MCG/DOSECIPLA LTD .PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESHINDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER01/07/2010
1274NDA/MAL/HDP/1400MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITED PANFOR SR 500METFORMIN HYDROCHLORIDE500MGINVENTIA HEALTHCARE LIMITED, F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - INDIAINDIAORAL SOLID RETARD TABLETS 1.0X5.0X20.0 TABLET BLISTER01/07/2015
1275NDA/MAL/HDP/1402MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITED PANFOR SR 1000METFORMIN HYDROCHLORIDE1000MGINVENTIA HEALTHCARE LIMITED, F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - INDIAINDIAORAL SOLID RETARD TABLETS 1.0X5.0X20.0 TABLET BLISTER01/07/2015
1276NDA/MAL/HDP/1406LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDCEBAY DRY SYRUPCEFIXIME TRIHYDRATE50MG/5MLLEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2014
1277NDA/MAL/HDP/1409PHARMACTIV FZCOJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN200MG/5MLNABIQASIM INDUSTRIES (PVT) LTD-, 17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.PAKISTANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X15.0 ML BOTTLE01/07/2007
1278NDA/MAL/HDP/1411LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDCIPIUMCHLORPHENIRAMINE4MGLEBEN LAB PVT LTD, L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2011
1279NDA/MAL/HDP/1414UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDDICLORAN SR TABLETSDICLOFENAC SODIUM100MGUNIQUE PHARMACEUTICAL LABS LIMITED. ., 215-216, 216-219, 304-308, GIDC PANOLI 394116-GUJARATINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2016
1280NDA/MAL/HDP/1417GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDMILICAL TABLETSCALCIUM CITRATE + VITAMIN D31000MG +200 I.UGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2001
1281NDA/MAL/HDP/1418SHOSAAN ASIC PACIFICRENE PHARMACY LTDAMINOPHYLLINE TABLETSAMINOPHYLLINE100MGNEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATEINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2011
1282NDA/MAL/HDP/1425LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDL-TRIMCOTRIMOXAZOLE240MG/5MLLEBEN LABORATORIES PVT. LTD, L-4, PHASE €“III, M.I.D.C, INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE01/07/2007
1283NDA/MAL/HDP/1426LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDMETROLEBMETRONIDAZOLE200MGLEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2015
1284NDA/MAL/HDP/1427GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTENA-50ATENOLOL50MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2011
1285NDA/MAL/HDP/1431INTAS PHARMACUITICALS LTD NORVIK ENTERPRISES LIMITEDTORTAS 10TORSEMIDE10MGINTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
1286NDA/MAL/HDP/1433BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORISTERATNORETHISTERONE ENANTATE200MGBAYER PHARMA A.G, MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYPARENTERAL ORDINARY VIALS 1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL01/07/1997
1287NDA/MAL/HDP/1436MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 10BISOPROLOL HEMIFUMARATE10MGMERCK KGAA, 250 FRANKFRUTER STRASSE 250-64293 DARMSTADT| WINTHROP PHARMACEUTICALS(PTY) LTD,, 315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE)GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
1288NDA/MAL/HDP/1445CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.AXONE 1000CEFTRIAXONE SODIUM1000MGCADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1000.0 MG VIAL01/07/2003
1289NDA/MAL/HDP/1446 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAMIN B COMPLEXVITAMINS B1 + B2 + B6 + NIACINAMIDE0.5 MG + 0.5MG + 7.5MGRENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER01/07/2015
1290NDA/MAL/HDP/1447EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDVITONA PLUSVITAMINS + MINERALSMULTI-INGREDIENT EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY, 10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES 1.0X2.0X6.0 CAPSULE BLISTER01/07/2014
1291NDA/MAL/HDP/1449SHAIGAN PHARMACEUTICALS (PVT) LTDHARLEYS UGANDA LIMITEDZEPAR SUSPENSIONALBENDAZOLE200MG/5MLSHAIGAN PHARMACEUTICALS (PVT) LTD, 14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTANPAKISTANORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE01/07/2000
1292NDA/MAL/HDP/1450GLAXOSMITHKLINE LIMITED LIKONIUNITED HEALTHCARE DISTRIBUTORS LTDVOLTAREN EMULGEL 1%DICLOFENAC DIETHYLAMMONIUM1%W/VGSK CONSUMER HEALTH SA, GSK CONSUMER HEALTH SA, ROUTE DE L€™ETRAZ, NYON, 1260, SWITZERLANDSWITZERLANDTOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE,1.0X50.0 G TUBE01/07/1997
1293NDA/MAL/HDP/1453ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZESOZ-40ESOMEPRAZOLE40MGMADRAS PHARMACEUTICALS -137-B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI €“ 600 096, INDIA |INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2016 00:00
1294NDA/MAL/HDP/1454 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDPAINEXPARACETAMOL + ASPIRIN + CAFFEINE500MG + 400MG + 50 MGRENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X25.0X4.0 TABLET STRIP01/07/2003
1295NDA/MAL/HDP/1456FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDSUCRAFIL O GELSUCRALFATE + OXETACAINE10MG + 0.2MGFOURRTS INDIA LABORATORIES PVT. LIMITED, VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2013
1296NDA/MAL/HDP/1457NABIQASIM INDUSTRIES (PVT) LTD. JEET PHARMACEUTICALS LIMITEDDYSEN FORTESECNIDAZOLE1000MGNABIQASIM INDUSTRIES (PVT) LIMITED, 17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET BLISTER01/07/2006
1297NDA/MAL/HDP/1459NVS KENYA LTD SURGIPHARM (U) LIMITEDTASIGNA 200NILOTINIB200MGNORVATIS PHARMA STEIN AG, SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY CAPSULES 1.0X2.0X14.0 CAPSULE BLISTER01/07/2010
1298NDA/MAL/HDP/1460VENUS REMEDIES LTDREDDYS PHARMA LIMITEDPARIN EENOXAPARIN80MGVENUS REMEDIES LTD -, UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X10.0X2.0X0.8 ML PRE- FILLED SYRINGE01/07/2009
1299NDA/MAL/HDP/1463ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDARISTOZYME LIQUIDDIASTASE+PEPSIN50MG+10MGARISTO PHARMACEUTICALS PVT. LIMITED, PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE01/07/2015
1300NDA/MAL/HDP/1465NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTFAST 50MGDICLOFENAC POTASSIUM50MGMIPHARM S.P.A , VIA BERNARDO QUARANTA, 12-20141, MILANO ITALY.ITALYORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X3.0 SACHET CARTON,9.0X1.0X3.0X3.0 SACHET CARTON01/07/2014
1301NDA/MAL/HDP/1468CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOCID 20OMEPRAZOLE20MG S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIAORAL SOLID RETARD CAPSULES 1.0X10.0X10.0 CAPSULE STRIP01/07/2014
1302NDA/MAL/HDP/1474GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODIC GELDICLOFENAC DIETHYLAMINE1%W/WAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE01/07/2016
1303NDA/MAL/HDP/1476GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDSEPTOLSILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE1%W/W + 0.20W/WAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE,1.0X15.0 G TUBE01/07/2016
1304NDA/MAL/HDP/1478AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRASILDENAFIL50MGAJANTA PHARMA LIMITED PAITHAN, MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER01/07/2001
1305NDA/MAL/HDP/1482SANOFI PASTEURLABOREX UGANDA LIMITEDSTAMARIL PASTEURYELLOW FEVER VIRUS 17D-204 STRAIN(LIVE ATTENUATED)NLT 1000 I.USANOFI PASTEUR, 1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY VIALS 1.0X1.0 DOSE VIAL + 0.5ML OF SOLVENT IN PRE-FILLED SYRINGE,1.0X10.0X10.0 DOSE VIAL + 1*10*10 DOSE AMPOULE OF NS01/07/1997
1306NDA/MAL/HDP/1485UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDUNITED HEALTHCARE DISTRIBUTORS LTDDICLOFEN 25DICLOFENAC25MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANRECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY BLISTER01/07/2011
1307NDA/MAL/HDP/1486ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-1AMPICILLIN1GREYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINACHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X1.0 G VIAL01/07/2011
1308NDA/MAL/HDP/1488DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDDICLO-DENK 100 RECTALDICLOFENAC SODIUM100MGHAUPT PHARMA WULFING GMBH., BETHELNER LANDSTR. 18, 31028 GRONAUGERMANYRECTAL SYSTEMIC ADULT SUPPOSITORIES 10.0X1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X5.0 SUPPOSITORY STRIP01/07/2000
1309NDA/MAL/HDP/1492DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDDICLO-DENK 75 INJECTIONDICLOFENAC SODIUM25MG/MLHAUPT PHARMA WULFING GMBH;-, BETHELNER LANDSTR. 18, 31028 GRONAULLEIRE, GERMANY.GERMANYPARENTERAL ORDINARY AMPOULES 1.0X10.0X3.0 ML AMPOULE01/07/1998
1310NDA/MAL/HDP/1497LABORATORY AND ALLIED LTDROYAL PHARMA 2011 LIMITEDLAEOVATE CREAMBETAMETHASONE VALERATE0.1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | TOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE01/07/1997
1311NDA/MAL/HDP/1499GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINEPROMETHAZINE HYDROCHLORIDE25MG/MLLABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESHINDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE01/07/2017
1312NDA/MAL/HDP/1503MEDICAL UNION PHARMACUITICALS KARURI PHARMACEUTICALS LTD.SEDIPROCT CREAMHYDROCORTISONE+CINCHOCAINE0.5%W/W + 0.5%W/WMEDICAL UNION PHARMA .CO, ABU-SULTAN ISMAILIA EGYPT EGYPTTOPICAL EXTERNAL OTHER CREAMS 1.0X20.0 G TUBE01/07/2003
1313NDA/MAL/HDP/1505GLAXOSMITHKLINE TRADING SERVICES LTD, UNITED HEALTHCARE DISTRIBUTORS LTDSERETIDE EVOHALERSALMETEROL/ FLUTICASONE PROPIONATE25/50 MCGGLAXO WELLCOME PRODUCTION, ZONE INDUSTRIELLE NO.2
23 RUE LAVOISER 27000 EVREUX		FRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X1.0 CANNISTER CARTON01/07/2007
1314NDA/MAL/HDP/1508DAWA LIMITED-SUPER MEDIC LTDWOMNILALBENDAZOLE200MG/5MLDAWA, PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE01/07/2009
1315NDA/MAL/HDP/1514JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE100MGJOHNSON & JOHNSON (PTY) LTD, 241 MAIN ROAD, RETREAT, 7945, CAPE TOWN| SPECPHARM HOLDINGS, 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X6.0 TABLET BLISTER01/07/1997
1316NDA/MAL/HDP/1516WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDURGENDOL PTRAMADOL/ PARACETAMOL37.5MG/ 325MGWIN MEDICARE PVT LIMITED, MEERUT, MUZAFFARNAGER ROAD, MODIPURAM €“ 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2011
1317NDA/MAL/HDP/1519ZYDUS LIFESCIENCES LTD.ABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 400BUDENOSIDE + FORMOTEROL FUMARATE120 METERED DOSES (400MCG/6MCG)ZYDUS LIFESCIENCES LIMITED, SURVEY NO. 417, 419 & 420, SARKHEJ - BAVLA NATIONAL HIGHWAY NO. 8A, VILLAGE - MORAIYA, TALUKA - SANAND, DIST. AHMEDABAD - 382 210, GUJARAT STATE - INDIAINDIALUNG ADMINISTRATION METERED-DOSE INHALER 1.0X1.0 CANNISTER CARTON01/07/2007
1318NDA/MAL/HDP/1523RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIRENAMPICILLIN 125MG/5MLRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2007
1319NDA/MAL/HDP/1524RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE125 MG / 5 MLRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2008
1320NDA/MAL/HDP/1525CIPLA LIMITED.ABACUS PHARMA (AFRICA) LIMITEDBENDEXALBENDAZOLE20MG/5MLCIPLA LTD ,,PLOT NO. 9,10,15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH PIN. 454774INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE01/07/2007
1321NDA/MAL/HDP/1527MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV AMOXICILLIN + CLAVULANATE POTASSIUM200MG + 28.5MG/ 5MLMICRO LABS LIMITED., PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE01/07/2012
1322NDA/MAL/HDP/1528MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV-625AMOXYCILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMICRO LABS LIMITED , PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X6.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER01/07/2007
1323NDA/MAL/HDP/1529BAYER PHARMA AGSURGIPHARM (U) LIMITEDPROVIRONMESTEROLONE25MGBAYER WEIMAR GMBH & CO. KG, DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X20.0 TABLET BLISTER01/07/1997
1324NDA/MAL/HDP/1533OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITED5DGLUCOSE50G/LOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD, VILLAGE €“ VASANA €“ CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE01/07/2007
1325NDA/MAL/HDP/1535ABACUS (A) PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFORTIWIN-4FORTIFIED PROCAINE PENICILLIN SODIUM4 M.UREYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA| INJECT CARE PARENTERALS PVT LTD, PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X4.0 MU VIAL,1.0X100.0X4.0 MU VIAL,1.0X10.0X4.0 MU VIAL01/07/2011
1326NDA/MAL/HDP/1537ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDELYZOLEALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED, ROAD B€™, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL SOLID ORDINARY TABLETS 1.0X20.0X2.0 TABLET BLISTER01/07/2005
1327NDA/MAL/HDP/1538ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDELYZOLE SUSPENSIONALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED, ROAD B€™, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE01/07/2003
1328NDA/MAL/HDP/1544GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINE HYDROCHLORIDE B.PPROMETHAZINE HCL25MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2004
1329NDA/MAL/HDP/1546UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLANPROLANSOPRAZOLE30MGUNICHEM LABORATORIES LTD, UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205| UNICHEM LABORATORIES LTD, PLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511INDIAORAL SOLID ORDINARY CAPSULES 1.0X5.0X2.0X10.0 CAPSULE BLISTER01/07/1999
1330NDA/MAL/HDP/1549REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.PREDNICOL EYE DROPSPREDNISOLONE 250MGREMINGTON PHARMACEUTICAL INDUS. PVT LTD, , 117 ALLAMPAKISTANOPHTHALMIC DROPS 1.0X10.0 ML VIAL01/07/1999
1331NDA/MAL/HDP/1551EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDCALOSHELL-500CALCIUM CARBONATE + VITAMIN D31250MG + 250IUEMCURE PHARMACEUTICALS LTD, LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2004
1332NDA/MAL/HDP/1553EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDVIFEXSALBUTAMOL + BROMHEXINE + GUAIFENESIN1MG/5ML+2MG/5ML+50MG/5MLEMCURE PHARMACEUTICALS LTD, LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2004
1333NDA/MAL/HDP/1554ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL CETIRIZINECETIRIZINE DIHYDROCHLORIDE5MG/5MLKOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA| KESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATMALAYSIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE01/07/2010
1334NDA/MAL/HDP/1555GALENTIC PHARMA LTDVITACARE LIMITEDGALSCRUBCHLORHEXIDINE4%W/WGALENTIC PHARMA PVT. LIMITED , R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL LIQUIDS 1.0X500.0 ML BOTTLE01/07/2008
1335NDA/MAL/HDP/1556VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDVOMISTATONDASENTRON2MG/MLLINCOLN PHARMACEUTICALS LTD, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE01/07/1997
1336NDA/MAL/HDP/1557GSK BIOLOGICALS SAUNITED HEALTHCARE DISTRIBUTORS LTDSYNFLORIX VACCINEPNEUMOCOCCAL POLYSACCHARIDE SEROTYPES (1,5,6B,7F,9V,14,23F) + (4,18C,19F) + PROTEIN D+TETANUS TOXOID+DIPTHERIA TOXOID CARRIER PROTEINS AND ALUMINIUM PHOSPHATE1MCG+3MCG+13MCG+8MCG+5MCG+0.5MGGLAXOSMITHKLINE BOILOGICALS, S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X100.0X0.5 ML VIAL (1 DOSE)01/07/2010
1337NDA/MAL/HDP/1563GLAXOSMITHKLINE TRADING SERVICES LTD, UNITED HEALTHCARE DISTRIBUTORS LTDAMOXILAMOXYCILLIN125MG/5MLGLAXO WELLCOME PRODUCTION., ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCEFRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/1997
1338NDA/MAL/HDP/1566GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDVITAVITMULTI-INGREDIENTMULTI-INGREDIENTAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA\NORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2009
1339NDA/MAL/HDP/1571BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDRHOCLONEMONOCLONAL ANTI-D IMMUNOGLOBULIN300MCGBHARAT SERUMS AND VACCINES LIMITED,, PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY DRY VIALS 1.0X2.0 ML VIAL (1 DOSE VIAL)01/07/2013
1340NDA/MAL/HDP/1572 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDROSUVAS 20ROSUVASTATIN20MGSUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED), VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2011
1341NDA/MAL/HDP/1574INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAMTAS-5AMLODIPINE5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION), CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 2.0X2.0X7.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER01/07/2003
1342NDA/MAL/HDP/1579PT SANBE FARMAMEDVIN PHARMA LIMITEDPLASMINEXTRANEXAMIC ACID100MG/MLPT SANBE FARMA JI INDUSTRI, NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X5.0 ML AMPOULE01/07/2011
1343NDA/MAL/HDP/1581MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPANTOTABPANTOPRAZOLE40MGMICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2006
1344NDA/MAL/HDP/1584ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDUCLOXCLOXACILLIN SODIUM500MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197 | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL01/07/2015
1345NDA/MAL/HDP/1585WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDUDIHEP FORTEURSODEOXYCHOLIC ACID300MGWIN-MEDICARE PRIVATE LIMITED, MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER01/07/2010
1346NDA/MAL/HDP/1588TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TOZAAR-HLOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50MG + 12.5MGTORRENT PHARMACEUTICALS LIMITED , AHMEDABAD-MEHSANA HIGHWAY, TAL. KADI, DIST. MEHSANA, INDRAD 382 721, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X4.0X7.0 TABLET BLISTER01/07/2005
1347NDA/MAL/HDP/1589CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDCENTACID SUSPENSIONMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE+SIMETHICONE40MG+200MG+250MG/5MLCENTAUR PHARMACEUTICALS PVT LTD, PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X170.0 ML BOTTLE01/07/1997
1348NDA/MAL/HDP/1591CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDCENTIPAR ELIXIRPIPERAZINE CITRATE750ML/5MLCENTAUR PHARMACEUTICALS PVT LTD, PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X30.0 ML BOTTLE01/07/1997
1349NDA/MAL/HDP/1598GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM 400CIMETIDINE400MGAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2005
1350NDA/MAL/HDP/1605RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDASPIRIN TABLETSACETYL SALICYLIC ACID300MGRENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER01/07/2001
1351NDA/MAL/HDP/1615AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPCALIS SXTADALAFIL20MGAJANTA PHARMA LIMITED PAITHAN, MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X2.0 TABLET BLISTER01/07/2005
1352NDA/MAL/HDP/1616GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCEZINCETIRIZINE5MG/5MLAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X30.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/2011
1353NDA/MAL/HDP/1627GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V GELCLOTRIMAZOLE2%W/WGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAVAGINAL GELS AND SOLS 1.0X30.0 G TUBE01/07/2004
1354NDA/MAL/HDP/1629INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 12.5CARVEDILOL12.5MGINTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2011
1355NDA/MAL/HDP/1631AUROBINDOM PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINE ORAL SUSPENSIONNEVIRAPINE50MG/5MLAUROBINDO PHARMA LTD, UNIT III , SURVEY NO. 313, 314 BACHUPALLY (VILLAGE) QUTHUBULLAPUR (MANDAL) RR DISTRICT HYDERABAD ANDHRA PRADESH 500090INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X240.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2007
1356NDA/MAL/HDP/1635CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ORITAXIM 1000MG INJECTIONCEFOTAXIME SODIUM1GMCADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0 G VIAL01/07/1997
1357NDA/MAL/HDP/1638AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFLADAZOLESECNIDAZOLE500MGAMOUN PHARMACEUTICALS CO. S.A.E, 1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER01/07/2005
1358NDA/MAL/HDP/1639GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL EXTRA WITH OPTIZORBPARACETAMOL + CAFFEINE500MG + 65MGGRANULES INDIA LIMITED, SY. NO. 160/A, 161/E, 162 & 174/A GAGILLAPUR VILLAGE, DUNDIGAL-GANDIMAISAMMA MANDAL, MEDCHAL - MALKHAJGIRI DISTRICT - 500043 TELENGANA| GLAXOSMITHKLINE DUNGARAVAN LTD, KNOCKBRACK DUNGARVAN CO. WATERFORDIRELANDORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON01/07/2003
1359NDA/MAL/HDP/1641UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDUNIENZYME C MPSNICOTINAMIDE+SIMETHICONE+PAPAIN+FUNGAL DIASTASE+CHARCOAL25MG+50MG+30MG+20MG+75MGUNICHEM LABORATORIES LIMITED, C€“31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2004
1360NDA/MAL/HDP/1650NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL CR 200CARBAMAZEPINE200MGNOVARTIS FARMA S.P.A., VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALYITALYORAL SOLID RETARD TABLETS 1.0X5.0X10.0 TABLET BLISTER01/07/2006
1361NDA/MAL/HDP/1651FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDMEGATRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLFOURTS (INDIA) LABORATORIES PRIVATE LIMITED , VANDALUR ROADINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1997
1362NDA/MAL/HDP/1652TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 300SODIUM VALPROATE300MGTORRENT PHARMACEUTICAL LTD, AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2009
1363NDA/MAL/HDP/1656AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDAZIGYL-500AZITHROMYCIN500MGMEDICO REMEDIES PVT LIMITED, 8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER01/07/2015
1364NDA/MAL/HDP/1660GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM-200CIMEDITINE200MGAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET STRIP01/07/2005
1365NDA/MAL/HDP/1663MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-PINKALUMINIUM HYDROXIDE/MAGNESIUM TRISILICATE400MG+400MG/50MLTORQUE PHARMACEUTICALS PVT LTD, ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE01/07/2003
1366NDA/MAL/HDP/1665GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN CAPSULESAMOXICILLIN TRIHYDRATE250MGCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD, NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407)| MILAN LABORATORIES (INDIA ) PVT LTD, PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIAINDIA| CHINAORAL SOLID ORDINARY CAPSULES 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/1998
1367NDA/MAL/HDP/1675MERCK SHARP & DOHME BVSURGIPHARM (U) LIMITEDGARDASILQUADRIVALENT HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE (TYPES 6, 11, 16, 18)(20MCG+40MCG+40MCG+20MCG)/0.5MLMERK & CO. INC, SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USAUNITED STATESPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X10.0X0.5 ML VIAL (1 DOSE)01/07/2007
1368NDA/MAL/HDP/1678ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDHYDROCORTISONE SODIUM SUCCINATEHYDROCORTISONE SODIUM SUCCINATE100MG/VIALINDASI LIFESCIENCE PRIVATE LIMITED, PLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN - 396210, INDIACHINAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X100.0 MG VIAL,1.0X50.0X100.0 MG VIAL01/07/2007
1369NDA/MAL/HDP/1679LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDCIPROLEBCIPROFLOXACIN500MGLEBEN LABORATORIES PVT. LTD., PLOT NO. L-4, PHASE €“III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2007
1370NDA/MAL/HDP/1680SHOSAAN ASIC PACIFICRENE PHARMACY LTDH-CORTHYDROCORTISONE0.1%W/WNEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATEINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/1997
1371NDA/MAL/HDP/1682VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDTOFLOX-200OFLOXACIN200MGLINCOLN PHARMACEUTICAL LIMITED, TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2005
1372NDA/MAL/HDP/1689SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDOMESKOMEPRAZOLE20MGS.KANT HEALTHCARE LTD, PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARATINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE STRIP01/07/2010
1373NDA/MAL/HDP/1690PHARMA INTERNATIONAL COWIDE SPECTRUM ENTERPRISES (U) LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE1MG/MLPHARMA INTERNATIONAL COMPANY, MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2004
1374NDA/MAL/HDP/1692PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOX 50MG/5ML SUSPENSIONCEFPODOXIME PROXETIL50MG/5MLPHARMA INTERNATIONAL CO.,, AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMANJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X50.0 ML BOTTLE01/07/2007
1375NDA/MAL/HDP/1693PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDOPTIMAL (0.05%) CREAMTRETINOIN USP0.5MG/1GPHARMA INTERNATIONAL COMPANY ., MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDANJORDANTOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE01/07/2005
1376NDA/MAL/HDP/1697PHARMA INTERNATIONAL COWIDE SPECTRUM ENTERPRISES (U) LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE10MGPHARMA INTERNATIONAL COMPANY, MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER01/07/2005
1377NDA/MAL/HDP/1701KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFORMIN METFORMIN HYDROCHLORIDE500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
1378NDA/MAL/HDP/1702PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDDELOR CLOBETASOL PROPIONATE0.05%W/WPHARMA INTERNATIONAL COMPANY, MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANTOPICAL EXTERNAL OINTMENTS 1.0X25.0 G TUBE01/07/2005
1379NDA/MAL/HDP/1707XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDFEBRICOL TABLETSPARACETAMOL / PSEUDOEPHEDRINE / CHLORPHENIRAMINE500MG / 30MG /2MGXEPA-SOUL PATTINSON (MALAYSIA) SDN BLD , 1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA		MALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER01/07/1997
1380NDA/MAL/HDP/1708LABORATORY AND ALLIED LTDROYAL PHARMA 2011 LIMITEDDENTAMOLACETAMINOPHEN500MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
| 		KENYA | ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER01/07/1997
1381NDA/MAL/HDP/1709REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDLUCIN CREAMHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE,1.0X15.0 G TUBE,1.0X5.0 G TUBE01/07/1997
1382NDA/MAL/HDP/1714REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.REMICOL EAR DROPSCHLORAMPHENICOL1%W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD, , 117 ALLAMPAKISTANOTIC DROPS 1.0X10.0 ML BOTTLE01/07/1999
1383NDA/MAL/HDP/1715SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCOLYN SYRUPAMMONIUM CHLORIDE+CHLORPHENIRAMINE+DEXTROMETHORPHAN+BROMHEXINE50MG+2MG+5MG+4MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | TANZANIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE03/06/2021
1384NDA/MAL/HDP/1723USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT MULTIVITAMIN DROPSMULTI-INGREDIENTMULTI-INGREDIENTSAKAR HEALTHCARE PVT LTD, SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESAINDIAORAL LIQUID ORDINARY DROPS 1.0X15.0 ML BOTTLE01/07/2000
1385NDA/MAL/HDP/1724GLAXOSMITHKLINE TRADING SERVICES LTD, UNITED HEALTHCARE DISTRIBUTORS LTDAVAMYS NASAL SPRAYFLUTICASONE FUROATE27.5MCG/ACTUATIONGLAXO OPERATIONS UK LTD--, HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK| GLAXO WELLCOME S.A, AVENIDA EXTREMADURA 3, 09400 ARANDA DE DUERO - SPAINUNITED KINGDOM, SPAINNASAL TOPICAL SPRAYS WITHOUT GAS 1.0X120.0 METERED DOSE CANNISTER01/07/2009
1386NDA/MAL/HDP/1725REMEDICA LTDGOODMAN INTERNATIONAL LTDMYCORIL CREAM 1%CLOTRIMAZOLE1%W/WREMEDICA LIMITED, LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSTOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2000
1387NDA/MAL/HDP/1728ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDDELISPRIN 75MGASPIRIN75MGARISTO PHARMACEUTICALS PVT LTD , PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X10.0X14.0 TABLET STRIP01/07/2007
1388NDA/MAL/HDP/1730COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN500MGCOSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER01/07/2008
1389NDA/MAL/HDP/1731REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDMEDIVEN-S OINTMENTBETAMETHASONE VALERATE + SALICYLIC ACID0.05%W/W + 3%W/WREGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE01/07/1997
1390NDA/MAL/HDP/1732MICRO LABS LTD LABOREX UGANDA LIMITEDCEFEX-250CEPHALEXIN250MGMICROLABS LIMITED, PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/1999
1391NDA/MAL/HDP/1734KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMOMINTCOMPOUND MAGNESIUM TRISILICATE500MGTIL HEALTH CARE, PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 10.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER01/07/1997
1392NDA/MAL/HDP/1736MEDOCHEMIE LTDLABOREX UGANDA LIMITEDKLERIMEDCLARITHROMYCIN 500MG MEDOCHEMIE (FACTORY AZ)., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER01/07/2009
1393NDA/MAL/HDP/1739MEDOCHEMIE LTDLABOREX UGANDA LIMITEDMELOX MELOXICAM15MG MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY, 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREACYPRUSORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER01/07/2009
1394NDA/MAL/HDP/1743MEDOCHEMIE LTDLABOREX UGANDA LIMITEDDAPRILLISINOPRIL DIHYDRATE10MGMEDOCHEMIE (FACTORY AZ)., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2009
1395NDA/MAL/HDP/1748GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-500AZITHROMYCIN500MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0 CAPSULE BLISTER01/07/2011
1396NDA/MAL/HDP/1761EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDATAZOR-RATAZANAVIR + RITONAVIR300 MG + 100 MGEMCURE PHARMACEUTICALS LTD ., PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE01/07/2014
1397NDA/MAL/HDP/1763LABORATORY&ALLIED LTDROYAL PHARMA 2011 LIMITEDASPIRIN TABLETS BPACETYL SALICYLIC ACID300MGLABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS 1.0X20.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/1997
1398NDA/MAL/HDP/1766 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOLDEASE CAPSULESPARACETAMOL+CAFFEINE CITRATE+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE400MG+30MG+4MG+30MGRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2005
1399NDA/MAL/HDP/1769GSK BIOLOGICALS SAUNITED HEALTHCARE DISTRIBUTORS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN10MCG/MLGLAXOSMITHKLINE BOILOGICALS, S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS 1.0X10.0X0.5 ML VIAL (1 DOSE),1.0X25.0X0.5 ML VIAL (1 DOSE)01/07/1997
1400NDA/MAL/HDP/1772 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDGESTID TABLETSCOMPOUND MAGNESIUM TRISILICATE385MGSUN PHARMACEUTICAL INDUSTRIES LIMITED,, INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X4.0 TABLET BLISTER01/07/2000
1401NDA/MAL/HDP/1773MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT 500LEVOFLOXACIN HEMIHYDRATE500MG MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2005
1402NDA/MAL/HDP/1777CIPLA LTD.ABACUS PHARMA (AFRICA) LIMITEDNUZAC 20FLUOXETINE20MGCIPLA LTD PLOT NO. L-139, VERNA, GOA 403 722 INDIA | INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2003
1403NDA/MAL/HDP/1779BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDPYODINE SOLUTION POVIDONE IODINE10.0G/100MLBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD, PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN		PAKISTANTOPICAL EXTERNAL LIQUIDS 1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE,1.0X500.0 ML BOTTLE01/07/1999
1404NDA/MAL/HDP/1780RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLRENE INDUSTRIES LIMITED, PLOT 680 KAMULI KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE01/07/2000
1405NDA/MAL/HDP/1781ASTRAZENECAMACNAUGHTON LIMITEDARIMIDEXANASTROZOLE1MGASTRAZENECA PHARMACEUTICALS LP, NEWARK, DELAWAREUNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER01/07/2000
1406NDA/MAL/HDP/1782GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER + LUMEFANTRINEPER 5ML: 15MG + 90MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE01/07/2010
1407NDA/MAL/HDP/1783LABORATORY AND ALLIED LTDROYAL PHARMA 2011 LIMITEDLAEOVATE OINTMENTBETAMETHASONE VALERATE0.1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X15.0 G TUBE01/07/1997
1408NDA/MAL/HDP/1785BETA HEALTHCARE INTERNATIONAL LIMITEDBETA HEALTHCARE UGANDA LIMITEDACTION TABLETSACETYL SALICYLATE + CAFFEINE + PARACETAMOL600MG+50MG+300MGBETA HEALTHCARE INTERNATIONAL LTD - , PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X200.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X110.0 TABLET STRIP,1.0X12.0 TABLET BLISTER01/07/1997
1409NDA/MAL/HDP/1786GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONAC TABLETS (THANE)DICLOFENAC50MGAGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/2001
1410NDA/MAL/HDP/1790REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNITRIM TABLETCO-TRIMOXAZOLE480MGREGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/1997
1411NDA/MAL/HDP/1792DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDLIPODARATORVASTATIN20MGDAR AL DAWA, NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
1412NDA/MAL/HDP/1796AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHA 250AZITHROMYCIN250 MGAJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130| AJANTA PHARMA LIMITED PAITHAN, MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER01/07/2006
1413NDA/MAL/HDP/1800MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMLONG-10AMLODIPINE10MGMICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2009
1414NDA/MAL/HDP/1801LABORATORY&ALLIED LTDROYAL PHARMA 2011 LIMITEDLABESTEN PESSARIESCLOTRIMAZOLE100MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | VAGINAL TABLETS 1.0X1.0X6.0 PESSARY STRIP01/07/1997
1415NDA/MAL/HDP/1803ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MGESOMEPRAZOLE40MGASTRAZENECA AB., GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON,1.0X28.0 TABLET CARTON01/07/2001
1416NDA/MAL/HDP/1809GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT-6PYRIDOXINE25MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2004
1417NDA/MAL/HDP/1810GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRITRIFLUOPERAZINE5MGAGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2010
1418NDA/MAL/HDP/1812 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREQUIN TABLETSQUININE SULPHATE300MGRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2001
1419NDA/MAL/HDP/1813DAWA LIMITEDSUPER MEDIC LTDMOXAFORTEAMOXICILLIN + FLUCLOXACILLIN125 MG + 125MGDAWA LTD, BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2014
1420NDA/MAL/HDP/1815GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSUPIROCIN OINTMENTMUPIROCIN2%W/WGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL OTHER OINTMENTS 1.0X15.0 G TUBE,1.0X5.0 G TUBE01/07/2003
1421NDA/MAL/HDP/1816MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDDRESS UP CREAMNEOMYCIN SULPHATE0.5%W/WTORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE01/07/1998
1422NDA/MAL/HDP/1819ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDCINAMET-200CIMETIDINE 200MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD , NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCECHINAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
1423NDA/MAL/HDP/1820CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDAZICIN-250AZITHROMYCIN250MGEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER01/07/2015
1424NDA/MAL/HDP/1821BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDMEFTAL 500 TABLETSMEFENAMIC ACID500MGBLUE CROSS LABORATORIES LTD, L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/1997
1425NDA/MAL/HDP/1822 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDEPHEDRINE EPHEDRINE HYDROCHLORIDE 30MGRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER01/07/2005
1426NDA/MAL/HDP/1825RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDCOLDEASE SYRUPPARACETAMOL+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE120MG+2MG+15MGRENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2005
1427NDA/MAL/HDP/1827REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDALBASOL SUSPENSIONALBENDAZOLE200MG/5MLREGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE01/07/2006
1428NDA/MAL/HDP/1840REMEDICA LTDGOODMAN INTERNATIONAL LTDOVA-MITCLOMIPHENE50MGREMEDICA LIMITED , AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER01/07/2011
1429NDA/MAL/HDP/1841MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDFUNGNIL CREAMCLOTRIMAZOLE1%W/WTORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2000
1430NDA/MAL/HDP/1842KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDSUGAQUIN TABLETSCHLOROQUINE PHOSPHATE250MGKAMPALA PHARMACEUTICALS INDUSTIES, PLOT NO M44B STRETCHER ROAD INTINDAUGANDAORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2002
1431NDA/MAL/HDP/1843USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDECORIN-75ASPIRIN75MGREMEDEX PHARMA, B-249/250 PEENYA INDUSTRIAL ESTATE BANGALORE 560 058
INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2005
1432NDA/MAL/HDP/1844GUILIN PHARMACEUTICALS CO.LTDTRIDEM PHARMA UGANDA LIMITEDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM800MG /160MGGUILIN PHARMACEUTICAL CO.LTD., NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINACHINAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2011
1433NDA/MAL/HDP/1846LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDANTAGIT DS GEL ORANGE FLAVOURALUMINIUM HYDROXIDE + MAGNESIUM + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT. LTD., PLOT NO. L-4, PHASE €“III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X170.0 ML BOTTLE01/07/2013
1434NDA/MAL/HDP/1847MICRO LABSMALIX PHARMA (U) LIMITEDMOXILEB-250 CAPSULEAMOXICILL