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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216035

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NDA 216035 describes RILUZOLE, which is a drug marketed by Alkem Labs Ltd, Apotex Corp, Daito Pharms Co Ltd, Glenmark Pharms Ltd, Impax Labs, Kenton, Pharmobedient, and Sun Pharm Inds Ltd, and is included in nine NDAs. It is available from five suppliers. Additional details are available on the RILUZOLE profile page.

The generic ingredient in RILUZOLE 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 216035

Tradename:	RILUZOLE
Applicant:	Alkem Labs Ltd
Ingredient:	riluzole
Patents:	0

Medical Subject Heading (MeSH) Categories for 216035

Anticonvulsants
Excitatory Amino Acid Antagonists
Neuroprotective Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	50MG/10ML
Approval Date:	Aug 22, 2024	TE:	AB	RLD:	No

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