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Last Updated: April 12, 2026

Generic Companies with Tentative Approvals for: dapagliflozin

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dapagliflozin 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 Laboratories Private Ltd	dapagliflozin	211478	10MG	TABLET;ORAL
Teva Pharms Usa Inc	dapagliflozin;metformin hydrochloride	211583	10MG/500MG	TABLET, EXTENDED RELEASE;ORAL
Sinotherapeutics Inc	dapagliflozin \|\| metformin	218091	5MG	TABLET
Inventia Healthcare Limited	dapagliflozin, metformin hydrochloride	219755	2.5MG	TABLET, EXTENDED RELEASE
Zydus Pharms	dapagliflozin	211582	10MG	TABLET;ORAL
Astrazeneca Ab	dapagliflozin; metformin hydrochloride	205649	10MG;1GM	TABLET, EXTENDED RELEASE;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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