You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

Details for New Drug Application (NDA): 091394

✉ Email this page to a colleague

« Back to Dashboard

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 four 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. Five 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.