Generic Companies with Tentative Approvals

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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
Emcure Pharma	nevirapine	078887	200MG	TABLET; ORAL
Sandoz Inc	sitagliptin; metformin hydrochloride	202388	50MG; 500MG	TABLET; ORAL
Accord Hlthcare Inc	perampanel	209877	6MG	TABLET;ORAL
Anchen Pharms	metformin hydrochloride; sitagliptin phosphate	204144	1GM; EQ 50MG BASE	TABLET, EXTENDED RELEASE;ORAL
Ranbaxy	fexofenadine hydrochloride	076970	60MG	TABLET; ORAL
Novast Labs Ltd	norgestimate; ethinyl estradiol	090541	0.18MG; 0.025MG	TABLET; ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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