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

Pharmacology for NDA: 021738

Mechanism of Action	Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for 021738

14-alpha Demethylase Inhibitors
Antifungal Agents
Cytochrome P-450 CYP3A Inhibitors

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:	RX	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	2%
Approval Date:	Jun 12, 2007	TE:	AT	RLD:	Yes

Expired US Patents for NDA 021738

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007	Start Trial	Start Trial
Mylan	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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