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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212640

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NDA 212640 describes EXSERVAN, which is a drug marketed by Aquestive and is included in one NDA. Additional details are available on the EXSERVAN profile page.

The generic ingredient in EXSERVAN is riluzole. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the riluzole profile page.

Summary for 212640

Tradename:	EXSERVAN
Applicant:	Aquestive
Ingredient:	riluzole
Patents:	0

Medical Subject Heading (MeSH) Categories for 212640

Anticonvulsants
Excitatory Amino Acid Antagonists
Neuroprotective Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM;ORAL			Strength	50MG
Approval Date:	Nov 22, 2019	TE:		RLD:	Yes

Expired US Patents for NDA 212640

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019	8,603,514	⤷ Get Started Free
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019	8,765,167	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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