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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 022071

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NDA 022071 describes LAMISIL, which is a drug marketed by Karo Hlthcare and Novartis and is included in eight NDAs. It is available from three suppliers. Additional details are available on the LAMISIL profile page.

The generic ingredient in LAMISIL is terbinafine. There are twenty-seven drug master file entries for this compound. Additional details are available on the terbinafine profile page.

Summary for 022071

Tradename:	LAMISIL
Applicant:	Novartis
Ingredient:	terbinafine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GRANULE;ORAL			Strength	EQ 125MG BASE/PACKET
Approval Date:	Sep 28, 2007	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GRANULE;ORAL			Strength	EQ 187.5MG BASE/PACKET
Approval Date:	Sep 28, 2007	TE:		RLD:	Yes

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