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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091394

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NDA 091394 describes RILUZOLE, which is a drug marketed by Apotex Corp, Sun Pharm Inds Ltd, Mylan Pharms Inc, Alkem Labs Ltd, Impax Labs, and Glenmark Pharms Ltd, 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: 091394

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091394

Ingredient-typeBenzothiazoles

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)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

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