Last Updated: May 3, 2026

Details for New Drug Application (NDA): 020192

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NDA 020192 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 020192

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 30, 1992	TE:		RLD:	No

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