Generic Companies with Tentative Approvals for: dolutegravir; lamivudine; tenofovir disoproxil fumarate
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dolutegravir; lamivudine; tenofovir disoproxil fumarate Generic Filers with Tentative Approvals
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Applicant | Generic Name | NDA | Strength | Dosage Form |
---|---|---|---|---|
Emcure Pharms Ltd | dolutegravir; lamivudine; tenofovir disoproxil fumarate | 211868 | 50MG/300MG/300MG | TABLET;ORAL |
Shanghai Desana Bio-pharmaceuticals Co Ltd | dolutegravir; lamivudine; tenofovir disoproxil fumarate | 213556 | 50MG; 300MG; 300MG | TABLET;ORAL |
Lupin Pharms | dolutegravir; lamivudine; tenofovir disoproxil fumarate | 212303 | 50MG/300MG/300MG | TABLET; ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |