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Serving leading biopharmaceutical companies globally:

Queensland Health
Fish and Richardson
McKesson
Johnson and Johnson
Federal Trade Commission
Healthtrust
UBS
Harvard Business School
Medtronic
Moodys

Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204048

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NDA 204048 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: 204048

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

Pharmacology for NDA: 204048

Ingredient-typeBenzothiazoles

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 0179-0217-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0217-70)
RILUZOLE
riluzole
TABLET;ORAL 204048 ANDA Ascend Laboratories, LLC 67877-286 67877-286-05 500 TABLET in 1 BOTTLE (67877-286-05)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Moodys
Farmers Insurance
Fuji
Harvard Business School
Argus Health
QuintilesIMS
Express Scripts
Teva
Colorcon

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