BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Citi
Federal Trade Commission
Johnson and Johnson
Colorcon
Julphar
Fuji
Teva
Baxter
Covington
Novartis

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022071

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NDA 022071 describes LAMISIL, which is a drug marketed by Glaxosmithkline, Novartis, and Glaxosmithkline Cons, 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 022071
Tradename:LAMISIL
Applicant:Novartis
Ingredient:terbinafine hydrochloride
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 022071
Ingredient-typeAllylamine
Suppliers and Packaging for NDA: 022071
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMISIL terbinafine hydrochloride GRANULE;ORAL 022071 NDA Novartis Pharmaceuticals Corporation 0078-0499 0078-0499-59 3 CARTON in 1 PACKAGE (0078-0499-59) > 14 PACKET in 1 CARTON (0078-0499-58) > 1 GRANULE in 1 PACKET (0078-0499-62)
LAMISIL terbinafine hydrochloride GRANULE;ORAL 022071 NDA Novartis Pharmaceuticals Corporation 0078-0499 0078-0499-58 14 PACKET in 1 CARTON (0078-0499-58) > 1 GRANULE in 1 PACKET (0078-0499-62)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:GRANULE;ORALStrengthEQ 125MG BASE/PACKET
Approval Date:Sep 28, 2007TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:GRANULE;ORALStrengthEQ 187.5MG BASE/PACKET
Approval Date:Sep 28, 2007TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Covington
Cantor Fitzgerald
Chinese Patent Office
Argus Health
Cipla
Farmers Insurance
McKinsey
Merck
Harvard Business School

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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