Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Deloitte
US Army
Colorcon
Cerilliant
Johnson and Johnson
UBS
Julphar
Fish and Richardson

Generated: December 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077533

« Back to Dashboard

NDA 077533 describes TERBINAFINE HYDROCHLORIDE, which is a drug marketed by Taro, Apotex, Aurobindo Pharma, Breckenridge Pharm, Cipla, 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 077533
Tradename:TERBINAFINE HYDROCHLORIDE
Applicant:Invagen Pharms
Ingredient:terbinafine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077533
Suppliers and Packaging for NDA: 077533
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077533 ANDA Rebel Distributors Corp 21695-630 21695-630-30 30 TABLET in 1 BOTTLE (21695-630-30)
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077533 ANDA Rebel Distributors Corp 21695-630 21695-630-42 42 TABLET in 1 BOTTLE (21695-630-42)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Jul 2, 2007TE: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:

Julphar
QuintilesIMS
Healthtrust
Daiichi Sankyo
Chubb
US Department of Justice
Harvard Business School
McKesson
Citi

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.