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Generated: December 14, 2018

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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 Alkem Labs Ltd, Apotex Corp, Daito Pharms Co Ltd, Glenmark Pharms Ltd, Impax Labs, Mylan Pharms Inc, and Sun Pharm Inds Ltd, and is included in seven NDAs. It is available from seven 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. Ten suppliers are listed for this compound. Additional details are available on the riluzole profile page.
Summary for 076173
Tradename:RILUZOLE
Applicant:Impax Labs
Ingredient:riluzole
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076173

Profile for product number 001

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

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