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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 020846

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NDA 020846 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 020846

Tradename:	LAMISIL
Applicant:	Karo Hlthcare
Ingredient:	terbinafine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TOPICAL			Strength	1%
Approval Date:	Apr 29, 1998	TE:		RLD:	No

Expired US Patents for NDA 020846

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Karo Hlthcare	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998	⤷ Get Started Free	⤷ Get Started Free
Karo Hlthcare	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998	⤷ Get Started Free	⤷ Get Started Free
Karo Hlthcare	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998	⤷ Get Started Free	⤷ Get Started Free
Karo Hlthcare	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998	⤷ Get Started Free	⤷ Get Started Free
Karo Hlthcare	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998	⤷ Get Started Free	⤷ Get Started Free
Karo Hlthcare	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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