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Last Updated: September 26, 2020

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Details for New Drug Application (NDA): 091300

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NDA 091300 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 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. Eleven suppliers are listed for this compound. Additional details are available on the riluzole profile page.
Summary for 091300
Applicant:Apotex Corp
Formulation / Manufacturing:see details
Pharmacology for NDA: 091300
Medical Subject Heading (MeSH) Categories for 091300
Suppliers and Packaging for NDA: 091300
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RILUZOLE riluzole TABLET;ORAL 091300 ANDA Apotex Corp 60505-3285 60505-3285-6 60 TABLET, FILM COATED in 1 BOTTLE (60505-3285-6)
RILUZOLE riluzole TABLET;ORAL 091300 ANDA American Health Packaging 68084-908 68084-908-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-908-25) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-908-95)

Profile for product number 001

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

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