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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021738

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NDA 021738 describes EXTINA, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. Additional details are available on the EXTINA profile page.

The generic ingredient in EXTINA is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 021738
Tradename:EXTINA
Applicant:Mylan
Ingredient:ketoconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021738
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-7007 0378-7007-01 1 CAN in 1 CARTON (0378-7007-01) > 100 g in 1 CAN
EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-7007 0378-7007-50 1 CAN in 1 CARTON (0378-7007-50) > 50 g in 1 CAN
Paragraph IV (Patent) Challenges for 021738
Tradename Dosage Ingredient NDA Submissiondate
EXTINA AEROSOL, FOAM;TOPICAL ketoconazole 021738 2009-07-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength2%
Approval Date:Jun 12, 2007TE:ATRLD:Yes

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