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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Harvard Business School
McKinsey
Federal Trade Commission
UBS
Express Scripts
US Department of Justice
QuintilesIMS
Baxter

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078462

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NDA 078462 describes TOPIRAMATE, which is a drug marketed by Zydus Pharms Usa Inc, Barr, Fosun Pharma, Mylan, Teva, Watson Labs, 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-nine NDAs. It is available from thirty-four 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 078462
Tradename:TOPIRAMATE
Applicant:Aurobindo Pharma
Ingredient:topiramate
Patents:0
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078462
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPIRAMATE topiramate TABLET;ORAL 078462 ANDA Citron Pharma LLC 57237-134 N 57237-134-60
TOPIRAMATE topiramate TABLET;ORAL 078462 ANDA Citron Pharma LLC 57237-135 N 57237-135-60

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 27, 2009TE:ABRLD:No

Profile for product number 003

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

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Cantor Fitzgerald
Merck
Deloitte
Colorcon
Cerilliant
McKesson
AstraZeneca
Julphar

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