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Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076327

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NDA 076327 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 forty-eight 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-two suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 076327
Tradename:TOPIRAMATE
Applicant:Sun Pharm Inds Ltd
Ingredient:topiramate
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 N 63304-778-30
TOPIRAMATE topiramate TABLET;ORAL 076327 ANDA Ranbaxy Pharmaceuticals Inc 63304-778 N 63304-778-10

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;ORALStrength100MG
Approval Date:Mar 27, 2009TE:ABRLD:No

Profile for product number 003

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

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