BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Moodys
Deloitte
McKinsey
Baxter
Cantor Fitzgerald
Chubb
Julphar
Healthtrust
Fish and Richardson
Express Scripts

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090162

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NDA 090162 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 090162
Tradename:TOPIRAMATE
Applicant:Unichem Labs Ltd
Ingredient:topiramate
Patents:0
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 090162
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPIRAMATE topiramate TABLET;ORAL 090162 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-115 29300-115-16 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-115-16)
TOPIRAMATE topiramate TABLET;ORAL 090162 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-115 29300-115-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-115-05)

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:

Chinese Patent Office
Fuji
Daiichi Sankyo
McKinsey
US Department of Justice
Covington
Farmers Insurance
UBS
Cipla

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