Generic Companies with Tentative Approvals for: dolutegravir
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dolutegravir 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 |
---|---|---|---|---|
Lupin Pharms | dolutegravir; lamivudine; tenofovir disoproxil fumarate | 212303 | 50MG/300MG/300MG | TABLET; ORAL |
Macleods Pharms Ltd | dolutegravir;lamivudine;tenofovir disoproxil fumarate | 210796 | 50MG/300MG/300MG | TABLET;ORAL |
Macleods Pharms Ltd | dolutegravir sodium | 214397 | EQ 50MG BASE | TABLET;ORAL |
Cipla Usa Inc. | dolutegravir lamivudine tenofovir alafenamide | 212527 | EQ 50MG BASE; 300MG; 25MG | TABLET, FOR SUSPENSION; ORAL |
Laurus Labs Ltd | dolutegravir;lamivudine;tenofovir disoproxil fumarate | 210787 | 50MG; 300MG;300MG | TABLET;ORAL |
Micro Labs Ltd | dolutegravir sodium | 212179 | 50MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |