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Last Updated: June 14, 2025

Generic Companies with Tentative Approvals for: metformin hydrochloride

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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
Novast Labs Ltd	metformin hydrochloride, sitagliptin	218069	50MG	TABLET, EXTENDED RELEASE
Msn Labs Pvt Ltd	metformin hydrochloride	211479	5MG; 1GM	TABLET, EXTENDED RELEASE; ORAL
Msn Labs Pvt Ltd	metformin hydrochloride	211479	10MG; 1GM	TABLET, EXTENDED RELEASE; ORAL
Prinston Pharmaceutical Inc	metformin hydrochloride, sitagliptin phosphate	216885	50MG	TABLET;FILM COATED
Ranbaxy Labs Ltd	metformin hydrochloride	076413	500MG	TABLET, EXTENDED RELEASE;ORAL
Zydus Pharms Usa Inc	metformin hydrochloride;sitagliptin phosphate	208535	50MG/500MG;50MG/1000MG	TABLET;ORAL
Novast Labs Ltd	metformin hydrochloride, sitagliptin	218069	1000MG	TABLET, EXTENDED RELEASE
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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