Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

How our clients use DrugPatentWatch

Generated: April 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091300

« Back to Dashboard
NDA 091300 describes RILUZOLE, which is a drug marketed by Apotex Corp, Sun Pharm Inds Ltd, Mylan Pharms Inc, Alkem Labs Ltd, Impax Labs, and Glenmark Generics, 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: 091300

Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091300


Suppliers and Packaging for NDA: 091300

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 091300 ANDA Apotex Corp 60505-3285 60505-3285-6 60 TABLET, FILM COATED in 1 BOTTLE (60505-3285-6)
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

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How our clients use DrugPatentWatch

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted

Follow DrugPatentWatch:

Google Plus