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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078235

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NDA 078235 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 078235
Tradename:TOPIRAMATE
Applicant:Zydus Pharms Usa Inc
Ingredient:topiramate
Patents:0
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078235
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPIRAMATE topiramate TABLET;ORAL 078235 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7562 N 0615-7562-39
TOPIRAMATE topiramate TABLET;ORAL 078235 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7562 N 0615-7562-05

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:

Express Scripts
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