Last Updated: May 18, 2026

Generic Companies with Tentative Approvals for: linagliptin

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linagliptin 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
Mylan Pharms Inc	linagliptin;metformin hydrochloride	208430	2.5MG;1GM	TABLET;ORAL
Mylan Pharms Inc	linagliptin;metformin hydrochloride	208430	2.5MG;850MG	TABLET;ORAL
Sun Pharm Inds Ltd	linagliptin and metformin hydrochloride	208454	2.5MG/500MG	TABLET; ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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