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Last Updated: July 6, 2020

DrugPatentWatch Database Preview

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. Thirty-six 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
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:OTCDosage:SOLUTION;TOPICALStrength1%
Approval Date:Mar 17, 2000TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SPRAY;TOPICALStrength1%
Approval Date:Mar 17, 2000TE:RLD:Yes

Expired US Patents for NDA 021124

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

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