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 |
---|---|---|---|---|
Laurus Generics Inc | dolutegravir | 215319 | 5MG | FILM;ORAL |
Macleods Pharms Ltd | dolutegravir sodium | 214397 | EQ 50MG BASE | TABLET;ORAL |
Lupin Pharms | dolutegravir;lamivudine;tenofovir alafenamide | 215187 | 50MG;300MG;25MG | TABLET; ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |