Last Updated: July 17, 2026

Generic Companies with Tentative Approvals for: empagliflozin

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empagliflozin 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
Aizant	empagliflozin	212322	10MG	TABLET;ORAL
Cipla Ltd	empagliflozin;metformin hydrochloride	212243	5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL
Zydus Pharms Usa Inc	empagliflozin;linagliptin;metformin hydrochloride	217049	25MG;5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL
Alkem Labs Ltd	empagliflozin	212382	25MG	TABLET;ORAL
Ajanta Pharma Ltd	empagliflozin, metformin hydrochloride	220511	12.5MG/1000MG	TABLET, EXTENDED RELEASE
Annora Pharma	empagliflozin	212365	25MG	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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