Last Updated: September 24, 2026

Details for New Drug Application (NDA): 206045

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NDA 206045 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 206045

Tradename:	RILUZOLE
Applicant:	Kenton
Ingredient:	riluzole
Patents:	0

Pharmacology for NDA: 206045

Medical Subject Heading (MeSH) Categories for 206045

Anticonvulsants
Excitatory Amino Acid Antagonists
Neuroprotective Agents

Suppliers and Packaging for NDA: 206045

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RILUZOLE	riluzole	TABLET;ORAL	206045	ANDA	AvKARE	42291-775	42291-775-60	60 TABLET, FILM COATED in 1 BOTTLE (42291-775-60)
RILUZOLE	riluzole	TABLET;ORAL	206045	ANDA	Florida Pharmaceutical Products, LLC	69076-200	69076-200-60	60 TABLET, FILM COATED in 1 BOTTLE (69076-200-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Dec 9, 2019	TE:	AB	RLD:	No

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