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Serving leading biopharmaceutical companies globally:

Argus Health
Novartis
UBS
Merck
Baxter
Deloitte
Queensland Health
Harvard Business School
Daiichi Sankyo
Teva

Generated: December 15, 2017

DrugPatentWatch Database Preview

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, 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. Eleven suppliers are listed for this compound. Additional details are available on the riluzole profile page.

Summary for 091300

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

Pharmacology for NDA: 091300

Ingredient-typeBenzothiazoles

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)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Julphar
US Army
Federal Trade Commission
AstraZeneca
Express Scripts
Medtronic
QuintilesIMS
Dow

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