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Last Updated: February 2, 2023

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
Lupin Pharms	dolutegravir; lamivudine; tenofovir disoproxil fumarate	212303	50MG/300MG/300MG	TABLET; ORAL
Macleods Pharms Ltd	dolutegravir;lamivudine;tenofovir disoproxil fumarate	210796	50MG/300MG/300MG	TABLET;ORAL
Macleods Pharms Ltd	dolutegravir sodium	214397	EQ 50MG BASE	TABLET;ORAL
Cipla Usa Inc.	dolutegravir lamivudine tenofovir alafenamide	212527	EQ 50MG BASE; 300MG; 25MG	TABLET, FOR SUSPENSION; ORAL
Laurus Labs Ltd	dolutegravir;lamivudine;tenofovir disoproxil fumarate	210787	50MG; 300MG;300MG	TABLET;ORAL
Micro Labs Ltd	dolutegravir sodium	212179	50MG	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

Baxter

Mallinckrodt

Merck

Express Scripts

Colorcon

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