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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Daiichi Sankyo
US Department of Justice
US Army

Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078297

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NDA 078297 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 078297
Applicant:Aurobindo Pharma
Ingredient:terbinafine hydrochloride
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 078297
Suppliers and Packaging for NDA: 078297
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078297 ANDA Lake Erie Medical DBA Quality Care Products LLC 55700-344 E 55700-344-60
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078297 ANDA Aurobindo Pharma Limited 65862-079 N 65862-079-99

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:

Johnson and Johnson
Chinese Patent Office
Queensland Health

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