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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 076314


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NDA 076314 describes TOPIRAMATE, which is a drug marketed by Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, Dr Reddys, Glenmark Pharms Ltd, Par Pharm, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, Barr, Fosun Pharma, Strides Pharma, Teva, Twi Pharms, Watson Labs, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Totowa, Ascent Pharms Inc, Aurobindo Pharma, Chartwell, Cipla Ltd, Glenmark Generics, Hikma Pharms, Invagen Pharms, Mylan, Pliva Hrvatska Doo, Roxane, Sun Pharm, Sun Pharm Inds Ltd, Torrent Pharms, Unichem Labs Ltd, Upsher Smith Labs, Viwit Pharm, and Wockhardt, and is included in forty NDAs. It is available from forty-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. Forty-nine suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 076314
Tradename:TOPIRAMATE
Applicant:Mylan
Ingredient:topiramate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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