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	terbinafine hydrochloride	077223	EQ 250MG BASE	TABLET;ORAL
Roxane	lamotrigine	077392	100MG	TABLET;ORAL
Roxane	nefazodone hydrochloride	076196	200MG	TABLET;ORAL
Roxane	tapentadol	205057	100MG	TABLET;ORAL
Roxane	nefazodone hydrochloride	076196	100MG	TABLET;ORAL
Roxane	fluconazole	076213	100MG	TABLET;ORAL
Roxane	mirtazapine	076270	15MG	TABLET;ORAL
Applicant	Generic Name	NDA	Strength	Dosage Form

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