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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
HA743 Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg Finished Pharmaceutical Product HIV/AIDS Cipla Ltd Tablet, Film-coated Prequalification - Full
HA698 Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg Finished Pharmaceutical Product HIV/AIDS Sun Pharmaceutical Industries Limited Tablet, Film-coated Prequalification - Full
HA662 Abacavir (sulfate)/Lamivudine Tablet, Dispersible 120mg/60mg Finished Pharmaceutical Product HIV/AIDS Cipla Ltd Tablet, Dispersible Prequalification - Full
HA763 Abacavir (sulfate)/Lamivudine Tablet, Dispersible 120mg/60mg Finished Pharmaceutical Product HIV/AIDS Micro Labs Limited Tablet, Dispersible Prequalification - Full
NDA 207369 USFDA Abacavir (sulfate)/Lamivudine Tablet 60mg/30mg Finished Pharmaceutical Product HIV/AIDS Hetero Labs Ltd Tablet Alternative Listing
ANDA 091144 USFDA Abacavir (sulfate)/Lamivudine Tablet 600mg/300mg Finished Pharmaceutical Product HIV/AIDS Cipla Ltd Tablet Alternative Listing
ANDA 205412 USFDA Abacavir (sulfate)/Lamivudine Tablet 600mg/300mg Finished Pharmaceutical Product HIV/AIDS Hetero Labs Ltd Tablet Alternative Listing
ANDA 210642 USFDA Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Film-coated 600mg/50mg/300mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet, Film-coated
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
HA791 Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60mg/5mg/30mg Finished Pharmaceutical Product HIV/AIDS ViiV Healthcare BV Tablet, Dispersible Prequalification - Abridged
HA779 Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60 mg/5 mg/30 mg Finished Pharmaceutical Product HIV/AIDS Cipla Ltd Tablet, Dispersible Prequalification - Full
HA106 Abacavir (sulfate) Tablet, Film-coated 300mg Finished Pharmaceutical Product HIV/AIDS ViiV Healthcare BV Tablet, Film-coated Prequalification - Abridged
HA674 Abacavir (sulfate) Tablet, Dispersible 60mg Finished Pharmaceutical Product HIV/AIDS Micro Labs Limited Tablet, Dispersible Prequalification - Full
ANDA 078742 USFDA Abacavir (sulfate) Tablet 300mg Finished Pharmaceutical Product HIV/AIDS Mylan Laboratories Limited Tablet Alternative Listing
ANDA 077844 USFDA Abacavir (sulfate) Tablet 300mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet Alternative Listing
ANDA 077950 USFDA Abacavir (sulfate) Solution, Oral 20mg/ml Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Solution, Oral Alternative Listing
HA107 Abacavir (sulfate) Solution, Oral 20mg/mL Finished Pharmaceutical Product HIV/AIDS ViiV Healthcare BV Solution, Oral Prequalification - Abridged
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