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Generated: January 16, 2019

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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 two suppliers. 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. Fifty-four 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 Novartis Consumer Health, Inc. 0067-4000 0067-4000-01 30 mL in 1 BOTTLE, PUMP (0067-4000-01)
LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0067-6292 0067-6292-83 125 mL in 1 BOTTLE, SPRAY (0067-6292-83)

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

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