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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 077065

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NDA 077065 describes TERBINAFINE HYDROCHLORIDE, which is a drug marketed by Taro, Aurobindo Pharma, Breckenridge Pharm, Chartwell, Cipla, Dr Reddys Labs Inc, Emed Medcl, Gedeon Richter Usa, Glenmark Pharms Ltd, Heritage Pharma Avet, Invagen Pharms, Mylan, Natco Pharma, Orbion Pharms, Roxane, and Wockhardt, and is included in sixteen NDAs. It is available from forty-one suppliers. Additional details are available on the TERBINAFINE HYDROCHLORIDE profile page.

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

Summary for 077065

Tradename:	TERBINAFINE HYDROCHLORIDE
Applicant:	Gedeon Richter Usa
Ingredient:	terbinafine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 250MG BASE
Approval Date:	Jul 2, 2007	TE:		RLD:	No

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