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Last Updated: October 27, 2021

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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
Cipla Ltd dolutegravir sodium 209658 50MG TABLET;ORAL
Mylan Pharms Inc dolutegravir;lamivudine;tenofovir disoproxil fumarate 209670 50MG;300MG;300MG TABLET;ORAL
Macleods Pharms Ltd dolutegravir sodium 214397 EQ 10MG BASE TABLET;ORAL
Macleods Pharms Ltd dolutegravir sodium 214397 EQ 25MG BASE TABLET;ORAL
Lupin Pharms dolutegravir; lamivudine; tenofovir disoproxil fumarate 212303 50MG/300MG/300MG TABLET; ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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Serving leading biopharmaceutical companies globally:

Dow
Medtronic
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Harvard Business School

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