Details for New Drug Application (NDA): 020599

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NDA 020599 describes RILUTEK, which is a drug marketed by Covis Pharma Bv and is included in one NDA. It is available from two suppliers. Additional details are available on the RILUTEK profile page.

The generic ingredient in RILUTEK is riluzole. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the riluzole profile page.

Summary for 020599

Tradename:	RILUTEK
Applicant:	Covis Pharma Bv
Ingredient:	riluzole
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020599

Medical Subject Heading (MeSH) Categories for 020599

Anticonvulsants
Excitatory Amino Acid Antagonists
Neuroprotective Agents

Suppliers and Packaging for NDA: 020599

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RILUTEK	riluzole	TABLET;ORAL	020599	NDA AUTHORIZED GENERIC	Rising Pharmaceuticals, Inc.	64980-191	64980-191-06	60 TABLET, FILM COATED in 1 BOTTLE (64980-191-06)
RILUTEK	riluzole	TABLET;ORAL	020599	NDA	Covis Pharma	70515-700	70515-700-60	1 BOTTLE in 1 CARTON (70515-700-60) > 60 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Dec 12, 1995	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020599

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis Pharma Bv	RILUTEK	riluzole	TABLET;ORAL	020599-001	Dec 12, 1995	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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