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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 203042

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NDA 203042 describes RILUZOLE, which is a drug marketed by Alkem Labs Ltd, Apotex Corp, Daito Pharms Co Ltd, Glenmark Pharms Ltd, Impax Labs, Kenton, Mylan Pharms Inc, and Sun Pharm Inds Ltd, and is included in nine NDAs. It is available from six 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. Seven suppliers are listed for this compound. Additional details are available on the riluzole profile page.

Summary for 203042

Tradename:	RILUZOLE
Applicant:	Mylan Pharms Inc
Ingredient:	riluzole
Patents:	0

Pharmacology for NDA: 203042

Medical Subject Heading (MeSH) Categories for 203042

Anticonvulsants
Excitatory Amino Acid Antagonists
Neuroprotective Agents

Suppliers and Packaging for NDA: 203042

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RILUZOLE	riluzole	TABLET;ORAL	203042	ANDA	Mylan Pharmaceuticals Inc.	0378-4145	0378-4145-91	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4145-91)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jul 1, 2013	TE:	AB	RLD:	No

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