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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Accenture
Merck
Julphar
Cipla
Fish and Richardson
Chinese Patent Office
US Department of Justice

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077714

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NDA 077714 describes TERBINAFINE HYDROCHLORIDE, which is a drug marketed by Taro, Apotex, Aurobindo Pharma, Breckenridge Pharm, Cipla Ltd, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Harris Pharm, Invagen Pharms, Mylan, Orchid Hlthcare, Roxane, Teva, and Wockhardt, and is included in sixteen NDAs. It is available from fifty-two suppliers. Additional details are available on the TERBINAFINE HYDROCHLORIDE profile page.

The generic ingredient in TERBINAFINE HYDROCHLORIDE is terbinafine hydrochloride. There are twenty-seven drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the terbinafine hydrochloride profile page.
Summary for 077714
Tradename:TERBINAFINE HYDROCHLORIDE
Applicant:Breckenridge Pharm
Ingredient:terbinafine hydrochloride
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 077714
Ingredient-typeAllylamine
Suppliers and Packaging for NDA: 077714
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077714 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-893 N 43353-893-16
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077714 ANDA Breckenridge Pharmaceutical, Inc. 51991-526 N 51991-526-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Jun 4, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Citi
Harvard Business School
Merck
UBS
US Army
Dow
Cipla
Teva

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