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

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204048

✉ Email this page to a colleague

« Back to Dashboard

NDA 204048 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 204048

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

Pharmacology for NDA: 204048

Medical Subject Heading (MeSH) Categories for 204048

Anticonvulsants
Excitatory Amino Acid Antagonists
Neuroprotective Agents

Suppliers and Packaging for NDA: 204048

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RILUZOLE	riluzole	TABLET;ORAL	204048	ANDA	Ascend Laboratories, LLC	67877-286	67877-286-05	500 TABLET in 1 BOTTLE (67877-286-05)
RILUZOLE	riluzole	TABLET;ORAL	204048	ANDA	Ascend Laboratories, LLC	67877-286	67877-286-10	1000 TABLET in 1 BOTTLE (67877-286-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Mar 30, 2016	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.