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Last Updated: April 15, 2026

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.

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Applicant	Generic Name	NDA	Strength	Dosage Form
Aurobindo Pharma Usa	dolutegravir, emtricitabine and tenofovir alafenamide	215448	50MG/200MG/25MG	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
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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