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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 075597

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NDA 075597 describes KETOCONAZOLE, which is a drug marketed by Padagis Israel, Xiromed, Encube, Fougera Pharms, Padagis Us, Teva, Cosette, Novitium Pharma, Zydus Lifesciences, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Senores Pharms, Strides Pharma, Sun Pharm Industries, and Taro, and is included in twenty NDAs. It is available from twenty-nine suppliers. Additional details are available on the KETOCONAZOLE profile page.

The generic ingredient in KETOCONAZOLE 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 075597

Tradename:	KETOCONAZOLE
Applicant:	Aurobindo Pharma Usa
Ingredient:	ketoconazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 075597

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Dec 23, 1999	TE:		RLD:	No

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