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	sumatriptan succinate	078241	EQ 25MG BASE	TABLET;ORAL
Roxane	tapentadol	205057	100MG	TABLET;ORAL
Roxane	nefazodone hydrochloride	076196	150MG	TABLET;ORAL
Roxane	sumatriptan succinate	078241	EQ 100MG BASE	TABLET;ORAL
Roxane	topiramate	076306	200MG	TABLET;ORAL
Roxane	topiramate	076306	50MG	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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