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Details for New Drug Application (NDA): 077533

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NDA 077533 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-three suppliers. Additional details are available on the TERBINAFINE HYDROCHLORIDE profile page.

The generic ingredient in TERBINAFINE HYDROCHLORIDE is terbinafine hydrochloride. There are twenty-four drug master file entries for this compound. Fifty-five suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the terbinafine hydrochloride profile page.

Summary for NDA: 077533

Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 077533


Suppliers and Packaging for NDA: 077533

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
terbinafine hydrochloride
TABLET;ORAL 077533 ANDA Rebel Distributors Corp 21695-630 21695-630-30 30 TABLET in 1 BOTTLE (21695-630-30)
terbinafine hydrochloride
TABLET;ORAL 077533 ANDA Rebel Distributors Corp 21695-630 21695-630-42 42 TABLET in 1 BOTTLE (21695-630-42)

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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