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Cipla
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US Army
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Dow
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Generated: June 24, 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 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 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 N 0078-0499-58
LAMISIL terbinafine hydrochloride GRANULE;ORAL 022071 NDA Novartis Pharmaceuticals Corporation 0078-0499 N 0078-0499-59

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 hundreds of leading biopharmaceutical companies globally:

Cerilliant
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Chinese Patent Office
Fuji
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