Details for New Drug Application (NDA): 021738

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NDA 021738 describes EXTINA, which is a drug marketed by Norvium Bioscience and is included in one NDA. 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. Thirty suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

Summary for 021738

Tradename:	EXTINA
Applicant:	Norvium Bioscience
Ingredient:	ketoconazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 021738

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 12, 2007	TE:		RLD:	Yes

Expired US Patents for NDA 021738

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Norvium Bioscience	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007	7,553,835	⤷ Try for Free
Norvium Bioscience	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007	8,026,238	⤷ Try for Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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