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 |
---|---|---|---|---|
Laurus Labs Ltd | dolutegravir;lamivudine;tenofovir disoproxil fumarate | 210787 | 50MG; 300MG;300MG | TABLET;ORAL |
Macleods Pharms Ltd | dolutegravir;lamivudine;tenofovir disoproxil fumarate | 210796 | 50MG/300MG/300MG | TABLET;ORAL |
Mylan Pharms Inc | dolutegravir;lamivudine;tenofovir disoproxil fumarate | 209670 | 50MG;300MG;300MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |