Medicines/Finished Pharmaceutical Products

E.g., 06/24/2018
E.g., 06/24/2018
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: 1 - 50 of 525
    WHO Reference Number International nonproprietary name (INN) Therapeutic Areasort descending Applicant Dosage form & strength Date of prequalification
    DI002 Zinc (sulfate) Diarrhoea Nutriset, BP 35, le Bois Ricard, Malaunay, 76770, France Tablet, Dispersible 20mg 04 Dec 2012
    DI004 Zinc (as sulfate) Diarrhoea Alkem Laboratories Ltd, Alkem House, "Devashish" Senapati Bapat Marg, Lower Parel, Mumbai, 400 013, India Tablet, Dispersible 20mg 19 Feb 2014
    DI005 Zinc sulfate Diarrhoea Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 20mg 07 Dec 2016
    HP001 Sofosbuvir Hepatitis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 400mg 20 Jul 2017
    HP002 Sofosbuvir Hepatitis Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 400mg 07 Feb 2018
    HP004 Sofosbuvir Hepatitis Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 400mg 05 Sep 2017
    HP005 (a) Entecavir Hepatitis Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 0.5mg 28 Nov 2017
    HP006 (a) Entecavir Hepatitis Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 1mg 28 Nov 2017
    HP007 (a) Daclatasvir (dihydrochloride) Hepatitis Bristol-Myers Squibb Company, P.O. Box 5400, New Jersey, United States of America Tablet, Film-coated 30mg 14 Oct 2016
    HP008 (a) Daclatasvir (dihydrochloride) Hepatitis Bristol-Myers Squibb Company, P.O. Box 5400, New Jersey, United States of America Tablet, Film-coated 60mg 14 Oct 2016
    NDA 200733 USFDA 2 Abacavir (sulfate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 60mg
    NDA 202381 USFDA 2 Abacavir (sulfate)/Lamivudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 60mg/30mg
    NDA 202814 USFDA 2 Lamivudine/Zidovudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 30mg/60mg
    NDA 203076 USFDA 2 Lamivudine/Nevirapine/Zidovudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 30mg/50mg/60mg
    NDA 204505 USFDA 2 Lamivudine/Tenofovir disoproxil fumarate + Nevirapine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 300mg/300mg + 200mg
    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 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 22342 USFDA 2 Lamivudine/Nevirapine/Stavudine 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 150mg/200mg/30mg
    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
    ANDA 0091611a USFDA 2 Atazanavir (sulfate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Capsules, hard 150mg
    ANDA 0091611b USFDA 2 Atazanavir (sulfate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Capsules, hard 300mg
    ANDA 077267 USFDA 1 Zidovudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 300mg
    ANDA 077268 USFDA 1 Zidovudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Solution, Oral 10mg/ml
    CSVMedicines/Finished Pharmaceutical Products