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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 204048

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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, 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 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

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