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Harvard Business School
Julphar
Accenture
McKinsey
Cerilliant
US Army
Merck
Chinese Patent Office
Cipla

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021385

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NDA 021385 describes ERTACZO, which is a drug marketed by Valeant Luxembourg and is included in one NDA. It is available from two suppliers. Additional details are available on the ERTACZO profile page.

The generic ingredient in ERTACZO is sertaconazole nitrate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the sertaconazole nitrate profile page.
Summary for 021385
Tradename:ERTACZO
Applicant:Valeant Luxembourg
Ingredient:sertaconazole nitrate
Patents:0
Therapeutic Class:Antifungals
Pharmacology for NDA: 021385
Ingredient-typeAzoles
Suppliers and Packaging for NDA: 021385
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERTACZO sertaconazole nitrate CREAM;TOPICAL 021385 NDA Valeant Pharmaceuticals North America LLC 0187-5115 N 0187-5115-02
ERTACZO sertaconazole nitrate CREAM;TOPICAL 021385 NDA Valeant Pharmaceuticals North America LLC 0187-5115 N 0187-5115-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2%
Approval Date:Dec 10, 2003TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
US Army
Cantor Fitzgerald
Baxter
McKesson
Daiichi Sankyo
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