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Last Updated: November 29, 2023

Details for New Drug Application (NDA): 020980

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NDA 020980 describes LAMISIL, which is a drug marketed by Glaxosmithkline, Novartis, and Glaxosmithkline Cons, and is included in eight NDAs. It is available from two 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 020980

Tradename:	LAMISIL
Applicant:	Glaxosmithkline
Ingredient:	terbinafine hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020980

Suppliers and Packaging for NDA: 020980

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020980	NDA	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	0067-3998	0067-3998-30	1 TUBE in 1 CARTON (0067-3998-30) / 30 g in 1 TUBE
LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020980	NDA	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	0067-3998	0067-3998-42	1 TUBE in 1 CARTON (0067-3998-42) / 12 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Mar 9, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 020980

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020980-001	Mar 9, 1999	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020980-001	Mar 9, 1999	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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