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
Macleods Pharms Ltd	dolutegravir sodium	214397	EQ 50MG BASE	TABLET;ORAL
Aurobindo Pharma Usa	dolutegravir, emtricitabine and tenofovir alafenamide	215448	50MG/200MG/25MG	TABLET; ORAL
Macleods Pharms Ltd	dolutegravir;lamivudine;tenofovir disoproxil fumarate	210796	50MG/300MG/300MG	TABLET;ORAL
Macleods Pharms Ltd	dolutegravir sodium	214397	EQ 10MG BASE	TABLET;ORAL
Laurus Labs Ltd	dolutegravir sodium	210963	50MG	TABLET; ORAL
Laurus Generics Inc	dolutegravir	215319	5MG	FILM;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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