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Serving leading biopharmaceutical companies globally:

Harvard Business School
Covington
Fish and Richardson
Queensland Health
US Army
Deloitte
UBS
Accenture
Medtronic
McKinsey

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077065

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NDA 077065 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-one 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-four suppliers are listed for this compound. Additional details are available on the terbinafine hydrochloride profile page.

Summary for 077065

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Jul 2, 2007TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Johnson and Johnson
Teva
US Army
Medtronic
Julphar
US Department of Justice
Express Scripts
Deloitte

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