Safinamide - Generic Drug Details

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Generic filers with tentative approvals for SAFINAMIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	100MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	50MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	100MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for safinamide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Aurobindo Pharma	SAFINAMIDE MESYLATE	safinamide mesylate	TABLET;ORAL	215902-001	Jun 14, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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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.