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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 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 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 NDA: 091300

Tradename:
RILUZOLE
Applicant:
Apotex Corp
Ingredient:
riluzole
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091300

Ingredient-typeBenzothiazoles

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)

Summary for product number 001

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


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