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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Daiichi Sankyo
Queensland Health
Johnson and Johnson
Chinese Patent Office

Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076390

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NDA 076390 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 076390
Applicant:Dr Reddys Labs Inc
Ingredient:terbinafine hydrochloride
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 076390
Suppliers and Packaging for NDA: 076390
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 076390 ANDA Dr.Reddys Laboratories Limited 55111-250 N 55111-250-05
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 076390 ANDA Dr.Reddys Laboratories Limited 55111-250 N 55111-250-30

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:

US Army
Harvard Business School
Federal Trade Commission

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