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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Chubb
Harvard Business School
Johnson and Johnson
Express Scripts
Queensland Health
Daiichi Sankyo
Fuji
Cantor Fitzgerald
Federal Trade Commission

Generated: September 21, 2017

DrugPatentWatch Database Preview

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 Labs, and is included in twenty-eight NDAs. It is available from forty-eight 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-one suppliers are listed for this compound. Additional details are available on the topiramate profile page.

Summary for NDA: 078462

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078462

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPIRAMATE
topiramate
TABLET;ORAL 078462 ANDA Citron Pharma LLC 57237-134 57237-134-60 60 TABLET, FILM COATED in 1 BOTTLE (57237-134-60)
TOPIRAMATE
topiramate
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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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Deloitte
UBS
Argus Health
Cipla
Accenture
Federal Trade Commission
Medtronic
Harvard Business School
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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