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Generated: May 24, 2017

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Details for New Drug Application (NDA): 078163

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NDA 078163 describes TERBINAFINE HYDROCHLORIDE, which is a drug marketed by Taro, Breckenridge Pharm, Harris Pharm, Roxane, Wockhardt, Invagen Pharms, Mylan, Cipla Ltd, Glenmark Generics, Orchid Hlthcare, Gedeon Richter Usa, Teva, Dr Reddys Labs Inc, Aurobindo Pharma, and Apotex, 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-five 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 NDA: 078163

Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 078163


Suppliers and Packaging for NDA: 078163

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
terbinafine hydrochloride
TABLET;ORAL 078163 ANDA Northstar Rx LLC 16714-501 16714-501-01 30 TABLET in 1 BOTTLE, PLASTIC (16714-501-01)
terbinafine hydrochloride
TABLET;ORAL 078163 ANDA Northstar Rx LLC 16714-501 16714-501-02 100 TABLET in 1 BOTTLE, PLASTIC (16714-501-02)

Summary for product number 001

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

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