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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Cantor Fitzgerald
Farmers Insurance
Citi
Cerilliant
Fuji
AstraZeneca
Daiichi Sankyo

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204048

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NDA 204048 describes RILUZOLE, which is a drug marketed by Alkem Labs Ltd, Apotex Corp, Glenmark Pharms Ltd, Impax Labs, Mylan Pharms Inc, and Sun Pharm Inds 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. Ten suppliers are listed for this compound. Additional details are available on the riluzole profile page.
Summary for 204048
Tradename:RILUZOLE
Applicant:Alkem Labs Ltd
Ingredient:riluzole
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204048
Ingredient-typeBenzothiazoles
Medical Subject Heading (MeSH) Categories for 204048
Suppliers and Packaging for NDA: 204048
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RILUZOLE riluzole TABLET;ORAL 204048 ANDA KAISER FOUNDATION HOSPITALS 0179-0217 N 0179-0217-70
RILUZOLE riluzole TABLET;ORAL 204048 ANDA Ascend Laboratories, LLC 67877-286 N 67877-286-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 30, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Teva
Cantor Fitzgerald
US Army
Deloitte
Baxter
Mallinckrodt
Argus Health
Fish and Richardson

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