Last Updated: July 13, 2026

Generic Companies with Tentative Approvals for: Lupin

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Lupin 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	minocycline hydrochloride	091424	EQ 55MG BASE	TABLET, EXTENDED RELEASE;ORAL
Lupin Ltd	dapagliflozin, saxagliptin monohydrate	211532	5MG	TABLET; ORAL
Lupin Ltd	dapagliflozin, saxagliptin monohydrate	211532	10MG	TABLET; ORAL
Lupin Ltd	ivacaftor	216074	150MG	TABLET; ORAL
Lupin	armodafinil	200751	50MG	TABLET;ORAL
Lupin Ltd	emtricitabine;tenofovir alafenamide	215071	200MG;25MG	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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