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US FDA Public Assessment Reports
(US FDA PARs)
Public Assessment Reports (PARs)
for HIV/AIDS
products approved or tentatively approved by the US
Food and Drug
Administration (US FDA)
and included on the WHO List of
Prequalified Medicines marked as USFDA1/USFDA2, are listed below.
NOTE: The list
below is in the process of being completed. To access the
available US FDA PARs click on hyper-link
US FDA PARs listed
alphabetically by product
Single
ingredient
2-Fixed Dose
Combinations (FDCs)
- Lamivudine 150mg + Zidovudine
300mg - Tablets - Aspen Pharmacare
- Lamivudine 150mg + Zidovudine
300mg - Tablets - Emcure Pharmaceuticals Limited
3-FDCs
- Lamivudine 150mg + Zidovudine
300mg + Nevirapine 200mg - Tablets - Aurobindo Pharma
Ltd
- Lamivudine 150mg + Stavudine 30mg
+ Nevirapine 200mg - Tablets - Strides Arcolab Ltd
- Lamivudine 150mg + Stavudine 40mg
+ Nevirapine 200mg - Tablets - Strides Arcolab Ltd
Co-packaged
FDCs
- [Lamivudine 150mg + Zidovudine
300mg] + Abacavir 300mg - Tablets - Aurobindo Pharma Ltd
- [Lamivudine 150mg + Zidovudine
300mg] + Nevirapine 200mg - Tablets - Aspen Pharmacare
- [Lamivudine 150mg + Zidovudine
300mg] + Nevirapine 200mg - Tablets - Strides Arcolab
Ltd
- [Lamivudine 150mg + Stavudine
40mg] + Nevirapine 200mg - Tablets - Strides Arcolab Ltd
- [Lamivudine 150mg + Stavudine
40mg] + Efavirenz 600mg - Tablets - Strides Arcolab Ltd
- [Lamivudine 150mg + Zidovudine
300mg] + Efavirenz 600mg - Tablets - Strides Arcolab Ltd
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- Prequalification:
US FDA PARs