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Medicines (Finished Pharmaceutical Products/Biotherapeutic products) - Prequalification

  • "+" means co-packaged product while “/” means fixed dose combination
  • [A/B] + C means A and B are in a fixed-dose formulation and C is co-packaged
Note:
  • For information about the listing of prequalified products and the alternative listing procedure, please see: General Information
  • Some products prequalified via abridged assessment may have different storage conditions and shelf life from those accepted by the reference authority. For more information, see WHOPAR part 1.
  • In product details page, the FPP sites that are used only for primary packaging are listed under “FPP Packaging only” section.
Displaying: 651 - 667 of 667
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WHO Reference Number INN, Dosage Form and Strength Product Type Therapeutic Area Applicant Dosage Form Basis of Listing Date of Prequalification
NDA 202814 USFDA Lamivudine/Zidovudine Tablet, Dispersible 30mg/60mg Finished Pharmaceutical Product HIV/AIDS Cipla Ltd Tablet, Dispersible Alternative Listing
ANDA 078887 USFDA Nevirapine Tablet 200mg Finished Pharmaceutical Product HIV/AIDS Emcure Pharmaceuticals Limited Tablet Alternative Listing
ANDA 203759 USFDA Ritonavir Tablet 100mg Finished Pharmaceutical Product HIV/AIDS Cipla Ltd Tablet Alternative Listing
ANDA 212579a USFDA Atazanavir (sulfate) Capsules, hard 150mg Finished Pharmaceutical Product HIV/AIDS Laurus Labs Limited Capsules, hard Alternative Listing
ANDA 213541 USFDA Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg Finished Pharmaceutical Product HIV/AIDS Laurus Labs Limited Tablet, Film-coated Alternative Listing
NDA 21837 USFDA Lamivudine/Nevirapine/Stavudine Tablet 150g/200mg/40mg Finished Pharmaceutical Product HIV/AIDS Strides Pharma Global PTE Limited Tablet Alternative Listing
ANDA 090198 USFDA Lamivudine Tablet, Film-coated 150mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet, Film-coated Alternative Listing
ANDA 090679 USFDA Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet, Film-coated Alternative Listing
ANDA 203232 USFDA Tenofovir disoproxil fumarate Tablet, Film-coated 300mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet, Film-coated Alternative Listing
ANDA 091579 USFDA Efavirenz Tablet, Film-coated 600mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet, Film-coated Alternative Listing
ANDA 203442 USFDA Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet, Film-coated Alternative Listing
NDA 214566 USFDA Dolutegravir (sodium) Tablet, Dispersible 10mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet, Dispersible Alternative Listing
ANDA 204739a USFDA Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet, Film-coated Alternative Listing
ANDA 204739b USFDA Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet, Film-coated Alternative Listing
NDA 210649 USFDA Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet, Film-coated Alternative Listing
NDA 210796 USFDA Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet, Film-coated Alternative Listing
NDA 217070 USFDA Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60mg/5mg/30mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet, Dispersible Alternative Listing
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