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Last Updated: February 27, 2021

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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	lamotrigine	077392	100MG	TABLET;ORAL
Roxane	topiramate	076306	200MG	TABLET;ORAL
Roxane	sumatriptan succinate	078241	EQ 50MG BASE	TABLET;ORAL
Roxane	lisdexamfetamine dimesylate	202827	20MG	CAPSULE;ORAL
Roxane	tapentadol	205057	75MG	TABLET;ORAL
Roxane	topiramate	076306	50MG	TABLET;ORAL
Roxane	lisdexamfetamine dimesylate	202827	60MG	CAPSULE;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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