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Details for New Drug Application (NDA): 078462

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NDA 078462 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: 078462

Aurobindo Pharma
Therapeutic Class:Anticonvulsants
Antimigraine Agents

Suppliers and Packaging for NDA: 078462

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 078462 ANDA Citron Pharma LLC 57237-134 57237-134-60 60 TABLET, FILM COATED in 1 BOTTLE (57237-134-60)
TABLET;ORAL 078462 ANDA Citron Pharma LLC 57237-135 57237-135-60 60 TABLET, FILM COATED in 1 BOTTLE (57237-135-60)

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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