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Last Updated: August 13, 2020

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Details for New Drug Application (NDA): 020749

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NDA 020749 describes LAMISIL, which is a drug marketed by Glaxosmithkline, Novartis, and Glaxosmithkline Cons, and is included in eight NDAs. It is available from one supplier. 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 020749
Tradename:LAMISIL
Applicant:Glaxosmithkline Cons
Ingredient:terbinafine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;TOPICALStrength1%
Approval Date:Oct 17, 1997TE:RLD:No

Expired US Patents for NDA 020749

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons LAMISIL terbinafine hydrochloride SOLUTION;TOPICAL 020749-001 Oct 17, 1997   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL terbinafine hydrochloride SOLUTION;TOPICAL 020749-001 Oct 17, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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