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Details for New Drug Application (NDA): 020599

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NDA 020599 describes RILUTEK, which is a drug marketed by Covis Pharma Sarl and is included in one NDA. It is available from five 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. Twelve suppliers are listed for this compound. Additional details are available on the riluzole profile page.

Summary for NDA: 020599

Covis Pharma Sarl
Therapeutic Class:Central Nervous System Agents

Pharmacology for NDA: 020599


Suppliers and Packaging for NDA: 020599

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 020599 NDA sanofi-aventis U.S. LLC 0075-7700 0075-7700-60 60 TABLET, FILM COATED in 1 BOTTLE (0075-7700-60)
TABLET;ORAL 020599 NDA KAISER FOUNDATION HOSPITALS 0179-0143 0179-0143-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0143-70)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 12, 1995TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020599

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Covis Pharma Sarl
TABLET;ORAL020599-001Dec 12, 19955,527,814<subscribe>
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