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Serving 500+ biopharmaceutical companies globally:

Cipla
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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022071

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NDA 022071 describes LAMISIL, which is a drug marketed by 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-five 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 NDA: 022071

Tradename:
1
Applicant:
1
Ingredient:
1
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 0078-0499-58 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 0078-0499-59 3 CARTON in 1 PACKAGE (0078-0499-59) > 14 PACKET in 1 CARTON (0078-0499-58) > 1 GRANULE in 1 PACKET (0078-0499-62)

Summary for product number 001

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

Summary for product number 002

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


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Serving 500+ biopharmaceutical companies globally:

Chubb
Covington
Mallinckrodt
US Department of Justice
Novartis
AstraZeneca
Baxter
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Accenture
Fish and Richardson

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