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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 076343


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NDA 076343 describes TOPIRAMATE, which is a drug marketed by Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, Dr Reddys, Endo Operations, Glenmark Pharms Ltd, Lupin Ltd, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Strides Pharma, Teva, Twi Pharms, Watson Labs, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Totowa, Aiping Pharm Inc, Ascent Pharms Inc, Aurobindo Pharma, Chartwell, Cipla Ltd, Hikma Pharms, Invagen Pharms, Natco, Pliva Hrvatska Doo, Roxane, Sun Pharm, Sun Pharm Inds Ltd, Torrent Pharms, Unichem Labs Ltd, Viwit Pharm, and Wockhardt, and is included in forty-three NDAs. It is available from fifty 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-four suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 076343
Tradename:TOPIRAMATE
Applicant:Cipla Ltd
Ingredient:topiramate
Patents:0
Suppliers and Packaging for NDA: 076343
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPIRAMATE topiramate TABLET;ORAL 076343 ANDA PD-Rx Pharmaceuticals, Inc. 43063-729 43063-729-07 7 TABLET in 1 BOTTLE, PLASTIC (43063-729-07)
TOPIRAMATE topiramate TABLET;ORAL 076343 ANDA PD-Rx Pharmaceuticals, Inc. 43063-729 43063-729-21 21 TABLET in 1 BOTTLE, PLASTIC (43063-729-21)

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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