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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Accenture
Baxter
Healthtrust
Fuji
AstraZeneca
US Department of Justice
Dow
US Army

Generated: April 26, 2018

DrugPatentWatch Database Preview

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 three 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. One supplier is listed for this compound. Additional details are available on the terbinafine profile page.
Summary for 020980
Tradename:LAMISIL
Applicant:Glaxosmithkline
Ingredient:terbinafine hydrochloride
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
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 Novartis Consumer Health, Inc. 0067-3998 N 0067-3998-30
LAMISIL terbinafine hydrochloride CREAM;TOPICAL 020980 NDA Novartis Consumer Health, Inc. 0067-3998 N 0067-3998-42

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM;TOPICALStrength1%
Approval Date:Mar 9, 1999TE:RLD:Yes

Expired US Patents for NDA 020980

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline LAMISIL terbinafine hydrochloride CREAM;TOPICAL 020980-001 Mar 9, 1999 ➤ Sign Up ➤ Sign Up
Glaxosmithkline LAMISIL terbinafine hydrochloride CREAM;TOPICAL 020980-001 Mar 9, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Accenture
Argus Health
McKesson
Cipla
Teva
AstraZeneca
Daiichi Sankyo

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