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Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077511

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NDA 077511 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 077511
Tradename:TERBINAFINE HYDROCHLORIDE
Applicant:Taro
Ingredient:terbinafine hydrochloride
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077511
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride CREAM;TOPICAL 077511 ANDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0067-8100 N 0067-8100-12
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride CREAM;TOPICAL 077511 ANDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0067-8100 N 0067-8100-15

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM;TOPICALStrength1%
Approval Date:Jul 2, 2007TE:RLD:No

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