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Serving leading biopharmaceutical companies globally:

Queensland Health
Federal Trade Commission
Fuji
Deloitte
Chinese Patent Office
US Department of Justice
Cantor Fitzgerald
Harvard Business School
QuintilesIMS
Moodys

Generated: November 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020980

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NDA 020980 describes LAMISIL, which is a drug marketed by Novartis, Glaxosmithkline Cons, and Glaxosmithkline, and is included in eight NDAs. It is available from four suppliers. Additional details are available on the LAMISIL profile page.

The generic ingredient in LAMISIL is terbinafine. There are twenty-six 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:
1
Applicant:
1
Ingredient:
1
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 0067-3998-30 1 TUBE in 1 CARTON (0067-3998-30) > 30 g in 1 TUBE
LAMISIL
terbinafine hydrochloride
CREAM;TOPICAL 020980 NDA Novartis Consumer Health, Inc. 0067-3998 0067-3998-42 1 TUBE in 1 CARTON (0067-3998-42) > 12 g in 1 TUBE

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020980

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
LAMISIL
terbinafine hydrochloride
CREAM;TOPICAL020980-001Mar 9, 1999► Subscribe► Subscribe
Glaxosmithkline
LAMISIL
terbinafine hydrochloride
CREAM;TOPICAL020980-001Mar 9, 1999► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Merck
US Army
Federal Trade Commission
US Department of Justice
Express Scripts
Julphar
UBS
Deloitte
McKesson
Fish and Richardson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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