Medicines/Finished Pharmaceutical Products

E.g., 06/17/2019
E.g., 06/17/2019
Formulation:
Legend:
  • "+" means combination product, both fixed-dose combination (co-formulated) and co-packaged product (i.e. co-blister)
  • [A+B] + C means A and B are in a fixed-dose formulation and C is co-packaged
  • (a) means SRA-approved innovator or SRA-approved generic that has been prequalified based on abbreviated assessment
  • "*" refers to products approved by both WHO and US FDA
  • USFDA1 approved by US FDA
  • USFDA2 tentatively approved by US FDA
  • EMA Art. 58 - approved by EMA according to Article 58

  • Note:
  • For information about the listing of prequalified products and the alternative approval procedure, please see: General Information
  • Click on the WHO REFERENCE NUMBER to see more detailed information

  • Displaying: 351 - 400 of 546
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalification
    NDA 205508 USFDA 2 Atazanavir (sulfate)/Ritonavir HIV/AIDS Emcure Pharmaceuticals Ltd, Plot No P-2, ITBT Park Phase II, M.I.D.C., Hinjwadi, Pune District, Maharashtra, 411 057, India Tablet 300mg/100mg
    NDA 207315 USFDA 2 Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Hetero Labs Ltd, Unit III, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India Tablet, Film-coated 75mg/75mg
    NDA 207369 USFDA 2 Abacavir (sulfate)/Lamivudine HIV/AIDS Hetero Labs Ltd, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet 60mg/30mg
    NDA 208255 USFDA 2 Efavirenz/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 400mg/300mg/300mg
    NDA 209618 USFDA 2 Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Aurobindo Pharma Ltd, Unit VII, SEZ, APIIC Plot No SI, Survey No 411, 425, 434, 435 and 458, Green Industrial Park, Village Polepally, Mandal Jedcherla, District Mahaboobnagar, Andhra Pradesh, India Tablet, Film-coated 50mg/300mg/300mg
    NDA 209670 USFDA 2 Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 50mg/300mg/300mg
    NDA 210787 USFDA 2 Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Laurus Labs Limited, 2nd Floor, Serene Chambers, Road 7, Banjara Hills, Hyderabad, Telangana, 500 034, India Tablet, Film-coated 50mg/300mg/300mg
    NDA 210880 USFDA 2 Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Hetero Labs Ltd, Unit III, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India Tablet, Film-coated 50mg/300mg/300mg
    NDA 21837a USFDA Lamivudine/Nevirapine/Stavudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 150mg/200mg/30mg
    NDA 21837b USFDA 2 Lamivudine/Nevirapine/Stavudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 150mg/200mg/40mg
    NDA 21841 USFDA 2 Lamivudine/Zidovudine + Nevirapine HIV/AIDS Aspen Pharmacare Ltd., PO Box 1587, Gallo Manor 2052, Woodlands Drive, Building 12, Healthcare Park, Woodmead, Johannesburg, Gauteng, 2191, South Africa Tablet 150mg/300mg + 200mg
    NDA 21854 USFDA 2 Lamivudine/Stavudine + Nevirapine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 150mg/40mg + 200mg
    NDA 21939 USFDA 2 Lamivudine/Nevirapine/Zidovudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 150mg/200mg/300mg
    NDA 21944 USFDA 2 Lamivudine/Zidovudine + Abacavir (sulfate) HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 150mg/300mg + 300mg
    NDA 22018 USFDA 2 Lamivudine/Zidovudine HIV/AIDS Aspen Pharmacare Ltd., PO Box 1587, Gallo Manor 2052, Woodlands Drive, Building 12, Healthcare Park, Woodmead, Johannesburg, Gauteng, 2191, South Africa Tablet 150mg/300mg
    NDA 22085a USFDA 2 Lamivudine/Stavudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 150mg/30mg
    NDA 22085b USFDA 2 Lamivudine/Stavudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 150mg/40mg
    NDA 22096 USFDA 2 Lamivudine/Zidovudine + Efavirenz HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 150mg/300mg + 600mg
    NDA 22097 USFDA 2 Lamivudine/Stavudine + Efavirenz HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India ; Tablet + Tablet; 150mg/40mg + 600mg
    NDA 22141 USFDA 2 Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 300mg/300mg
    NDA 22177 USFDA 2 Lamivudine/Nevirapine/Stavudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 150mg/200mg/30mg
    NDA 22295 USFDA Abacavir (sulfate)/Lamivudine HIV/AIDS Aurobindo Pharma Ltd, Unit 3, Survey No 313, Bachupally, Hyderabad, Quthubllaur (M), Rangareddy District, Andhra Pradesh, 500 072, India Tablet, Film-coated 60mg/30mg
    NDA 22296 USFDA 2 Lamivudine/Zidovudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 30mg/60mg
    NDA 22299 USFDA 2 Nevirapine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet, Dispersible 50mg
    NDA 22343 USFDA 2 Efavirenz/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 600mg/300mg/300mg
    NDA 22344 USFDA 2 Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 300mg/300mg
    NDA 22461a USFDA 2 Efavirenz HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 50mg
    NDA 22461b USFDA 2 Efavirenz HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 100mg
    NDA 22461c USFDA 2 Efavirenz HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 200mg
    NDA 22537 USFDA 2 Lamivudine/Nevirapine/Stavudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 150mg/200mg/30mg
    NDA 22541 USFDA 2 Lamivudine/Stavudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 150mg/30mg
    NDA 21943 USFDA 2 Lamivudine/Zidovudine + Efavirenz HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 150mg/300mg + 600mg
    NT001 (a) Diethylcarbamazine (citrate) Neglected Tropical Diseases (NTD) Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet 100mg 06 Sep 2016
    NT002 Diethylcarbamazine (citrate) Neglected Tropical Diseases (NTD) Eisai Co Ltd, 4-6-10 Koishikawa, Bunkyo-Ku, Tokyo, 112-8088, Japan Tablet 100mg 20 Aug 2013
    NT003 Praziquantel Neglected Tropical Diseases (NTD) Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 600mg 16 Dec 2015
    NT004 Praziquantel Neglected Tropical Diseases (NTD) Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 600mg 05 Sep 2017
    NT006 Mebendazole Neglected Tropical Diseases (NTD) Janssen-Cilag International NV, Turnhoutseweg 30, Beerse, 2340, Belgium Tablets, Chewable 500mg 05 Apr 2019
    RH002 (a) Levonorgestrel Reproductive Health Jenapharm GmbH & Co. KG, Otto-Schott-Str. 15, 07745, Jena, Germany Tablet, coated 30mcg 26 May 2009
    RH013 Ethinylestradiol/Levonorgestrel Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Sugar coated 30mcg/150mcg 29 Sep 2011
    RH017 (a) Levonorgestrel Reproductive Health Bayer Pharma AG, Müllerstraße 178, Berlin, 13353, Germany Rod 75mg 23 Sep 2009
    RH018 (a) Medroxyprogesterone acetate Reproductive Health Pfizer Manufacturing Belgium NV / SA, Rijksweg 12, Puurs 2870, Belgium Suspension for injection 150mg/mL 20 Aug 2010
    RH021 (a) Lynestrenol Reproductive Health NV Organon, Kloosterstraat 6, Moleneind, AB Oss, 5349 AB, Netherlands Tablet 500mcg 02 Jun 2010
    RH022 (a) Norethisterone enantate Reproductive Health Bayer AG, Müllerstraße 178, Berlin, 13353, Germany Solution for injection 200mg/ml 05 Oct 2011
    RH025 (a) Desogestrel/Ethinylestradiol + Placebo Reproductive Health NV Organon, Kloosterstraat 6, Moleneind, AB Oss, 5349 AB, Netherlands Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 0.150mg/0.030mg + 0mg 29 Sep 2010
    RH028 Levonorgestrel Reproductive Health Shanghai Dahua Pharmaceutical Co Ltd, 3503 Changzheng Road, Changzheng Farm, Chongming County, Shanghai, China (People's Republic of) Implant 75mg per rod (150mg in total) 30 Jun 2017
    RH030 Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Ethinylestradiol/Levonorgestrel Tablet + Placebo Tablet 0.03mg/0.150mg + 0mg 22 Dec 2011
    RH031 Levonorgestrel Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 1.5mg 21 Oct 2013
    RH032 Levonorgestrel Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 750mcg 14 Jun 2013
    RH035 Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Sugar coated 30mcg/150mcg + 0mg 21 Oct 2013
    RH036 (a) Etonogestrel Reproductive Health N V Organon, Oss, 5349 AB, Netherlands Implant 68mg 23 May 2013
    CSVMedicines/Finished Pharmaceutical Products