Last Updated: July 13, 2026

Generic Companies with Tentative Approvals for: saxagliptin

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saxagliptin 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
Glenmark Pharms Ltd	saxagliptin hydrochloride	205994	EQ 2.5MG BASE	TABLET;ORAL
Amneal Pharms	saxagliptin;metformin hydrochloride	205942	2.5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL
Par Pharm	saxagliptin	205959	5MG	TABLET;ORAL
Amneal Pharms	saxagliptin;metformin hydrochloride	205942	5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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