BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Argus Health
Cipla
Fish and Richardson
Fuji
Deloitte
Colorcon
UBS
Moodys
Cerilliant
Queensland Health

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090278

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NDA 090278 describes TOPIRAMATE, which is a drug marketed by Barr, Mylan, Sandoz, Teva, Watson Labs, Zydus Pharms Usa Inc, 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-eight NDAs. It is available from forty-nine 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-three suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 090278
Tradename:TOPIRAMATE
Applicant:Sun Pharma Global
Ingredient:topiramate
Patents:0
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 090278
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPIRAMATE topiramate TABLET;ORAL 090278 ANDA Apotheca Inc. 12634-083 12634-083-82 12 TABLET, FILM COATED in 1 BOTTLE (12634-083-82)
TOPIRAMATE topiramate TABLET;ORAL 090278 ANDA Apotheca Inc. 12634-083 12634-083-85 15 TABLET, FILM COATED in 1 BOTTLE (12634-083-85)

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 leading biopharmaceutical companies globally:

Cantor Fitzgerald
Julphar
Mallinckrodt
Teva
Baxter
Dow
Chubb
Farmers Insurance
McKesson

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