Tentative Approvals for: Roxane

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Roxane Drugs with Tentative Approvals

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Applicant	Generic Name	NDA	Strength	Dosage Form
Roxane	lamotrigine	077392	25MG	TABLET;ORAL
Roxane	lisdexamfetamine dimesylate	202827	20MG	CAPSULE;ORAL
Roxane	olanzapine	077993	5MG	TABLET; ORAL
Roxane	tapentadol	205057	75MG	TABLET;ORAL
Roxane	fluconazole	076213	200MG	TABLET;ORAL
Roxane	acyclovir	074570	200MG	CAPSULE;ORAL
Roxane	alprazolam	074199	0.5MG	TABLET;ORAL
Applicant	Generic Name	NDA	Strength	Dosage Form

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