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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 091394


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NDA 091394 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. Nine suppliers are listed for this compound. Additional details are available on the riluzole profile page.
Summary for 091394
Tradename:RILUZOLE
Applicant:Glenmark Pharms Ltd
Ingredient:riluzole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091394
Medical Subject Heading (MeSH) Categories for 091394
Suppliers and Packaging for NDA: 091394
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RILUZOLE riluzole TABLET;ORAL 091394 ANDA Glenmark Pharmaceuticals Inc., USA 68462-381 68462-381-10 1000 TABLET, FILM COATED in 1 BOTTLE (68462-381-10)
RILUZOLE riluzole TABLET;ORAL 091394 ANDA Glenmark Pharmaceuticals Inc., USA 68462-381 68462-381-60 60 TABLET, FILM COATED in 1 BOTTLE (68462-381-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jun 18, 2013TE:ABRLD:No

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