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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Mallinckrodt
Daiichi Sankyo
Medtronic
McKinsey
Chinese Patent Office
Covington
Johnson and Johnson

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077555

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NDA 077555 describes TIAGABINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms Co, Sun Pharm Inds, and Wilshire Pharms Inc, and is included in three NDAs. It is available from two suppliers. Additional details are available on the TIAGABINE HYDROCHLORIDE profile page.

The generic ingredient in TIAGABINE HYDROCHLORIDE is tiagabine hydrochloride. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.
Summary for 077555
Tradename:TIAGABINE HYDROCHLORIDE
Applicant:Sun Pharm Inds
Ingredient:tiagabine hydrochloride
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 077555
Suppliers and Packaging for NDA: 077555
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIAGABINE HYDROCHLORIDE tiagabine hydrochloride TABLET;ORAL 077555 ANDA Sun Pharmaceutical Industries Limited 62756-200 N 62756-200-18
TIAGABINE HYDROCHLORIDE tiagabine hydrochloride TABLET;ORAL 077555 ANDA Sun Pharmaceutical Industries Limited 62756-200 N 62756-200-83

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Nov 4, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Nov 4, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
UBS
Merck
Mallinckrodt
Teva
McKesson
Federal Trade Commission
Covington
Chinese Patent Office

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