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Details for New Drug Application (NDA): 076311

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NDA 076311 describes TOPIRAMATE, which is a drug marketed by Pliva Hrvatska Doo, Sandoz, Roxane, Lupin, Accord Hlthcare, Mylan, Barr, Teva, Glenmark Generics, Sun Pharm Inds Ltd, Apotex Inc, Zydus Pharms Usa Inc, Actavis Totowa, Cipla Ltd, Watson Labs, Torrent Pharms, Wockhardt Usa, Aurobindo Pharma, Invagen Pharms, Unichem Labs Ltd, Sun Pharma Global, Hikma Pharms, and Upsher Smith, and is included in twenty-eight NDAs. It is available from fifty-five 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-eight suppliers are listed for this compound. Additional details are available on the topiramate profile page.

Summary for NDA: 076311

Tradename:
TOPIRAMATE
Applicant:
Accord Hlthcare
Ingredient:
topiramate
Patents:0
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 076311

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPIRAMATE
topiramate
TABLET;ORAL 076311 ANDA Major Pharmaceuticals 0904-6016 0904-6016-04 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6016-04)
TOPIRAMATE
topiramate
TABLET;ORAL 076311 ANDA Major Pharmaceuticals 0904-6017 0904-6017-04 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6017-04)

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;ORALStrength50MG
Approval Date:Mar 27, 2009TE:ABRLD:No

Summary for product number 003

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


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