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Last Updated: July 6, 2020

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Details for New Drug Application (NDA): 204430


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NDA 204430 describes RILUZOLE, which is a drug marketed by Alkem Labs Ltd, Apotex Corp, Daito Pharms Co Ltd, Glenmark Pharms Ltd, Impax Labs, Kenton, Mylan Pharms Inc, and Sun Pharm Inds Ltd, and is included in eight NDAs. It is available from six 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 204430
Tradename:RILUZOLE
Applicant:Daito Pharms Co Ltd
Ingredient:riluzole
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 204430

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Oct 16, 2018TE:RLD:No

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