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Details for New Drug Application (NDA): 076173

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NDA 076173 describes RILUZOLE, which is a drug marketed by Apotex Corp, Sun Pharm Inds Ltd, Mylan Pharms Inc, Alkem Labs Ltd, Impax Labs, and Glenmark Generics, and is included in six NDAs. It is available from eight 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. Twelve suppliers are listed for this compound. Additional details are available on the riluzole profile page.

Summary for NDA: 076173

Impax Labs
Therapeutic Class:Central Nervous System Agents

Pharmacology for NDA: 076173


Suppliers and Packaging for NDA: 076173

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 076173 ANDA Global Pharmaceuticals, Division of Impax Laboratories, Inc. 0115-3000 0115-3000-01 100 TABLET, FILM COATED in 1 BOTTLE (0115-3000-01)
TABLET;ORAL 076173 ANDA Global Pharmaceuticals, Division of Impax Laboratories, Inc. 0115-3000 0115-3000-02 500 TABLET, FILM COATED in 1 BOTTLE (0115-3000-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 29, 2003TE:ABRLD:No

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