Last Updated: September 24, 2026

Details for New Drug Application (NDA): 091394

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NDA 091394 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 is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the riluzole profile page.

Summary for 091394

Tradename:	RILUZOLE
Applicant:	Glenmark Pharms Ltd
Ingredient:	riluzole
Patents:	0

Pharmacology for NDA: 091394

Medical Subject Heading (MeSH) Categories for 091394

Anticonvulsants
Excitatory Amino Acid Antagonists
Neuroprotective Agents

Suppliers and Packaging for NDA: 091394

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RILUZOLE	riluzole	TABLET;ORAL	091394	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-381	68462-381-10	1000 TABLET, FILM COATED in 1 BOTTLE (68462-381-10)
RILUZOLE	riluzole	TABLET;ORAL	091394	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-381	68462-381-60	60 TABLET, FILM COATED in 1 BOTTLE (68462-381-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jun 18, 2013	TE:	AB	RLD:	No

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