Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Healthtrust
QuintilesIMS
Colorcon
Merck
Deloitte
Fuji
Chinese Patent Office
Novartis

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077714

« Back to Dashboard

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-three suppliers. Additional details are available on the TERBINAFINE HYDROCHLORIDE profile page.

The generic ingredient in TERBINAFINE HYDROCHLORIDE is terbinafine hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-five 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 51991-526-33

Profile for product number 001

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Accenture
Harvard Business School
US Army
Julphar
Fuji
Boehringer Ingelheim
Healthtrust
Baxter

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.

botpot