Generic Companies with Tentative Approvals for: Roxane

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Roxane 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
Roxane	nefazodone hydrochloride	076196	100MG	TABLET;ORAL
Roxane	rosiglitazone maleate	078695	2MG	TABLET; ORAL
Roxane	alprazolam	074199	0.5MG	TABLET;ORAL
Roxane	nefazodone hydrochloride	076196	250MG	TABLET;ORAL
Roxane	alprazolam	074199	1MG	TABLET;ORAL
Roxane	topiramate	076306	200MG	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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