Last Updated: July 17, 2026

Generic Companies with Tentative Approvals for: empagliflozin;metformin hydrochloride

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empagliflozin;metformin hydrochloride 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
Msn Labs Pvt Ltd	empagliflozin;metformin hydrochloride	212362	5MG/1000MG	TABLET, EXTENDED RELEASE; ORAL
Lupin Ltd	empagliflozin;metformin hydrochloride	213654	10MG; 1GM	TABLET, EXTENDED RELEASE;ORAL
Macleods Pharms Ltd	empagliflozin;metformin hydrochloride	212373	5MG;1000MG	TABLET;ORAL
Msn Labs Pvt Ltd	empagliflozin;metformin hydrochloride	212362	25MG/1000MG	TABLET, EXTENDED RELEASE; ORAL
Macleods Pharms Ltd	empagliflozin;metformin hydrochloride	212373	5MG;500MG	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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