Details for New Drug Application (NDA): 021124

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NDA 021124 describes LAMISIL AT, which is a drug marketed by Glaxosmithkline Cons and is included in two NDAs. It is available from one supplier. Additional details are available on the LAMISIL AT profile page.

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

Summary for 021124

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

Pharmacology for NDA: 021124

Suppliers and Packaging for NDA: 021124

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LAMISIL AT	terbinafine hydrochloride	SOLUTION;TOPICAL	021124	NDA	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	0067-6296	0067-6296-01	125 mL in 1 CAN (0067-6296-01)
LAMISIL AT	terbinafine hydrochloride	SOLUTION;TOPICAL	021124	NDA	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	0067-6297	0067-6297-01	125 mL in 1 CAN (0067-6297-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SOLUTION;TOPICAL			Strength	1%
Approval Date:	Mar 17, 2000	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	SPRAY;TOPICAL			Strength	1%
Approval Date:	Mar 17, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021124

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Cons	LAMISIL AT	terbinafine hydrochloride	SPRAY;TOPICAL	021124-002	Mar 17, 2000	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline Cons	LAMISIL AT	terbinafine hydrochloride	SPRAY;TOPICAL	021124-002	Mar 17, 2000	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline Cons	LAMISIL AT	terbinafine hydrochloride	SOLUTION;TOPICAL	021124-001	Mar 17, 2000	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline Cons	LAMISIL AT	terbinafine hydrochloride	SOLUTION;TOPICAL	021124-001	Mar 17, 2000	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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