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Last Updated: September 28, 2020

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Generic Companies with Tentative Approvals for: Amneal

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Amneal 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
Amneal Pharms	saxagliptin;metformin hydrochloride	205942	5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL
Amneal Pharms	saxagliptin;metformin hydrochloride	205942	5MG;500MG	TABLET, EXTENDED RELEASE;ORAL
Amneal Pharms	lisdexamfetamine dimesylate	202830	60MG	CAPSULE;ORAL
Amneal Pharms	estradiol	211396	0.05MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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