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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
HA109 Zidovudine Capsules, hard 250mg Finished Pharmaceutical Product HIV/AIDS ViiV Healthcare UK Limited Capsules, hard Prequalification - Abridged
HA114 Zidovudine Solution for injection 10mg/mL Finished Pharmaceutical Product HIV/AIDS ViiV Healthcare UK Limited Solution for injection Prequalification - Abridged
HA486 Zidovudine Solution, Oral 10mg Finished Pharmaceutical Product HIV/AIDS Hetero Labs Ltd Solution, Oral Prequalification - Full
HA526 Zidovudine Solution, Oral 10mg/mL Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Solution, Oral Prequalification - Full
ANDA 077268 USFDA Zidovudine Solution, Oral 10mg/ml Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Solution, Oral Alternative Listing
HA115 Zidovudine Solution, Oral 50mg/5mL Finished Pharmaceutical Product HIV/AIDS ViiV Healthcare UK Limited Solution, Oral Prequalification - Abridged
ANDA 077267 USFDA Zidovudine Tablet 300mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet Alternative Listing
ANDA 078922 USFDA Zidovudine Tablet 300mg Finished Pharmaceutical Product HIV/AIDS Mylan Laboratories Limited Tablet Alternative Listing
HA483 Zidovudine Tablet, Film-coated 300mg Finished Pharmaceutical Product HIV/AIDS Micro Labs Limited Tablet, Film-coated Prequalification - Full
HA537 Zidovudine Tablet, Film-coated 60mg Finished Pharmaceutical Product HIV/AIDS Micro Labs Limited Tablet, Film-coated Prequalification - Full
DI010 Zinc (sulfate) Syrup 10mg/5ml Finished Pharmaceutical Product Diarrhoea PharmEvo (Pvt) Ltd. Syrup Prequalification - Full
DI011 Zinc (sulfate) Tablet, Dispersible 20mg Finished Pharmaceutical Product Diarrhoea Ipca Laboratories Ltd Tablet, Dispersible Prequalification - Full
DI014 Zinc (sulfate) Tablet, Dispersible 20mg Finished Pharmaceutical Product Diarrhoea Swiss Pharma Nigeria Ltd. Tablet, Dispersible Prequalification - Full
DI013 Zinc (sulfate) Tablet, Dispersible 20mg Finished Pharmaceutical Product Diarrhoea The ACME Laboratories Ltd Tablet, Dispersible Prequalification - Full
DI009 Zinc (sulfate) Tablet, Dispersible 20mg Finished Pharmaceutical Product Diarrhoea PharmEvo (Pvt) Ltd. Tablet, Dispersible Prequalification - Full
DI005 Zinc (sulfate) Tablet, Dispersible 20mg Finished Pharmaceutical Product Diarrhoea Macleods Pharmaceuticals Ltd Tablet, Dispersible Prequalification - Full
DI002 Zinc (sulfate) Tablet, Dispersible 20mg Finished Pharmaceutical Product Diarrhoea Laboratoires Pharmaceutiques Rodael Tablet, Dispersible Prequalification - Full
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