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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Chinese Patent Office
Farmers Insurance

Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077919

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NDA 077919 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 077919
Applicant:Harris Pharm
Ingredient:terbinafine hydrochloride
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 077919
Suppliers and Packaging for NDA: 077919
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077919 ANDA AvKARE, Inc. 42291-805 N 42291-805-30
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077919 ANDA PD-Rx Pharmaceuticals, Inc. 55289-054 N 55289-054-42

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Argus Health
Cantor Fitzgerald
Boehringer Ingelheim
US Department of Justice

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