Medicines/Finished Pharmaceutical Products

E.g., 12/17/2017
E.g., 12/17/2017
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 512
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalification
    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 077275a USFDA 2 Didanosine HIV/AIDS Aurobindo Pharma Ltd, Unit 3, Survey No 313, Bachupally, Hyderabad, Quthubllaur (M), Rangareddy District, Andhra Pradesh, 500 072, India Tablet, Dispersible 200mg
    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, Survey No 51, 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
    ANDA 090198b USFDA Lamivudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Anheri-Kurla Road, Andheri (E), Mumbai, 400 059, India Tablet, Film-coated 300mg
    ANDA 090309 USFDA 2 Abacavir (sulfate)/Lamivudine/Zidovudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 300mg/150mg/300mg
    ANDA 090437 USFDA 2 Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 600mg/200mg/300mg
    ANDA 090457 USFDA 2 Lamivudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 300mg
    ANDA 090471a USFDA 2 Lopinavir/Ritonavir HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 100mg/25mg
    ANDA 090471b USFDA 2 Lopinavir/Ritonavir HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 200mg/50mg
    ANDA 090488 USFDA 2 Emtricitabine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Capsules, hard 200mg
    ANDA 090513 USFDA 2 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 200mg/300mg
    ANDA 090647 USFDA 2 Tenofovir disoproxil fumarate HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 300mg
    ANDA 090688 USFDA Nevirapine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Anheri-Kurla Road, Andheri (E), Mumbai, 400 059, India Tablet 200mg
    CSVMedicines/Finished Pharmaceutical Products