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Generated: November 17, 2018

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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 Bv and is included in one NDA. It is available from three 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
Applicant:Covis Pharma Bv
Formulation / Manufacturing:see details
Pharmacology for NDA: 020599
Medical Subject Heading (MeSH) Categories for 020599
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 KAISER FOUNDATION HOSPITALS 0179-0143 0179-0143-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0143-70)
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)

Profile for product number 001

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

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