Last Updated: August 18, 2026

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.

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Applicant	Generic Name	NDA	Strength	Dosage Form
Lupin Pharms	dolutegravir; lamivudine; tenofovir disoproxil fumarate	212303	50MG/300MG/300MG	TABLET; ORAL
Lachman Consultant Services , Inc.	dolutegravir; lamivudine; tenofovir disoproxil fumarate	219804	50MG; 300MG; 300MG	TABLET; ORAL
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
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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