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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091417

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NDA 091417 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 091417

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

Pharmacology for NDA: 091417

Ingredient-typeBenzothiazoles

Medical Subject Heading (MeSH) Categories for 091417

Suppliers and Packaging for NDA: 091417

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RILUZOLE riluzole TABLET;ORAL 091417 ANDA KAISER FOUNDATION HOSPITALS 0179-0150 0179-0150-70 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0179-0150-70)
RILUZOLE riluzole TABLET;ORAL 091417 ANDA Sun Pharmaceutical Industries Limited 62756-538 62756-538-88 100 TABLET, FILM COATED in 1 BOTTLE (62756-538-88)

Summary for product number 001

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


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