Medicines/Finished Pharmaceutical Products

E.g., 12/19/2018
E.g., 12/19/2018
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 526
    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
    HP003 Sofosbuvir Hepatitis European Egyptian Pharmaceuticals Industries Co, PO Box 111, El Manshia Alex, Cairo Desert Road KM 25, Amriya, Alexandria, Egypt Tablet, Film-coated 400mg 18 Dec 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
    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
    ANDA 077275b USFDA 2 Didanosine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablets, Chewable 100mg
    ANDA 077275c USFDA 2 Didanosine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablets, Chewable 150mg
    ANDA 077464a USFDA 2 Lamivudine HIV/AIDS Aurobindo Pharma Ltd, Unit 3, Survey No 313, Bachupally, Hyderabad, Quthubllaur (M), Rangareddy District, Andhra Pradesh, 500 072, India Tablet 150mg
    ANDA 077464b USFDA 2 Lamivudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 300mg
    ANDA 077521 USFDA 2 Nevirapine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 200mg
    ANDA 077558 USFDA 2 Lamivudine/Zidovudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 150mg/300mg
    ANDA 077672a USFDA 1 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 15mg
    ANDA 077672b USFDA 1 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 20mg
    ANDA 077672c USFDA 2 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 30mg
    ANDA 077672d USFDA 2 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 40mg
    ANDA 077673 USFDA 2 Efavirenz HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 600mg
    ANDA 077695 USFDA 1 Lamivudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Solution, Oral 10mg/ml
    ANDA 077702 USFDA 2 Nevirapine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Suspension, Oral 50mg/5ml
    ANDA 077774 USFDA 2 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Powder for Oral solution 1mg/ml
    ANDA 077844 USFDA 2 Abacavir (sulfate) HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 300mg
    ANDA 077950 USFDA 2 Abacavir (sulfate) HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Solution, Oral 20mg/ml
    ANDA 078064a USFDA 2 Efavirenz HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 50mg
    ANDA 078064b USFDA 2 Efavirenz HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 200mg
    ANDA 078064c USFDA 2 Efavirenz HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 100mg
    ANDA 078128 USFDA 1 Zidovudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 100mg
    ANDA 078545 USFDA 2 Lamivudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 300mg
    ANDA 078587 USFDA 2 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 Capsules, hard 40mg
    ANDA 078644 USFDA 2 Nevirapine HIV/AIDS Zhejiang Huahai Pharmaceutical Co Ltd, Xunqiao, Linhai, Zhejiang Province, 317 024, China (People's Republic of) Tablet 200mg
    ANDA 078742 USFDA 2 Abacavir (sulfate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 300mg
    ANDA 078785a USFDA 2 Atazanavir (sulfate) HIV/AIDS Emcure Pharmaceuticals Ltd, Plot No P-2, ITBT Park Phase II, M.I.D.C., Hinjwadi, Pune District, Maharashtra, 411 057, India Capsules, hard 100mg
    ANDA 078785b USFDA 2 Atazanavir (sulfate) HIV/AIDS Emcure Pharmaceuticals Ltd, Plot No P-2, ITBT Park Phase II, M.I.D.C., Hinjwadi, Pune District, Maharashtra, 411 057, India Capsules, hard 200mg
    ANDA 078785c USFDA 2 Atazanavir (sulfate) HIV/AIDS Emcure Pharmaceuticals Ltd, Plot No P-2, ITBT Park Phase II, M.I.D.C., Hinjwadi, Pune District, Maharashtra, 411 057, India Capsules, hard 150mg
    ANDA 078850a USFDA 2 Lamivudine HIV/AIDS Hetero Labs Ltd, Unit III, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India Tablet, Film-coated 150mg
    ANDA 078850b USFDA 2 Lamivudine HIV/AIDS Hetero Labs Ltd, Hetero House, H No 8-3-166/7/1, Erragadda, Hyderabad, Andhra Pradesh, 500 018, India Tablet 300mg
    ANDA 078887 USFDA 2 Nevirapine 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 200mg
    ANDA 078922 USFDA 1 Zidovudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 300mg
    ANDA 078929 USFDA 2 Lamivudine/Zidovudine 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/300mg
    ANDA 078958 USFDA 2 Efavirenz 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 600mg
    ANDA 079124 USFDA 2 Lamivudine/Zidovudine HIV/AIDS Hetero Labs Ltd, Hetero House, H No 8-3-166/7/1, Erragadda, Hyderabad, Andhra Pradesh, 500 018, India Tablet 150mg/300mg
    ANDA 079188 USFDA 2 Emtricitabine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 200mg
    CSVMedicines/Finished Pharmaceutical Products