.

Deeper Knowledge, Faster

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

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

Serving leading biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
Harvard Business School
Accenture
Cantor Fitzgerald
Chubb
Julphar
Queensland Health
QuintilesIMS
Medtronic

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076327

« Back to Dashboard

NDA 076327 describes TOPIRAMATE, which is a drug marketed by Barr, Mylan, Sandoz, Teva, Watson Labs, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Totowa, Apotex Inc, Aurobindo Pharma, Cipla Ltd, Glenmark Generics, Invagen Pharms, Lupin, Pliva Hrvatska Doo, Roxane, Sun Pharm Inds Ltd, Sun Pharma Global, Torrent Pharms, Unichem Labs Ltd, Upsher-smith Labs, Wockhardt Usa, and Hikma Pharms, and is included in twenty-eight NDAs. It is available from forty-nine suppliers. Additional details are available on the TOPIRAMATE profile page.

The generic ingredient in TOPIRAMATE is topiramate. There are twenty-six drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the topiramate profile page.

Summary for 076327

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 076327

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPIRAMATE topiramate TABLET;ORAL 076327 ANDA Ranbaxy Pharmaceuticals Inc 63304-778 63304-778-10 1000 TABLET, FILM COATED in 1 BOTTLE (63304-778-10)
TOPIRAMATE topiramate TABLET;ORAL 076327 ANDA Ranbaxy Pharmaceuticals Inc 63304-778 63304-778-30 30 TABLET, FILM COATED in 1 BOTTLE (63304-778-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Mar 27, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Mar 27, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Mar 27, 2009TE:ABRLD:No


Complete Access Available with Subscription
« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

Moodys
Novartis
Julphar
McKinsey
AstraZeneca
Baxter
Medtronic
Fuji
Daiichi Sankyo
Chubb

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
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot