Last Updated: November 13, 2026

Details for New Drug Application (NDA): 215185

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NDA 215185 describes KETOCONAZOLE, which is a drug marketed by Padagis Israel, Xiromed, Encube, Fougera Pharms, Padagis Us, Teva, Cosette Pharms Nc, Novitium Pharma, Zydus Lifesciences, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Pharmazone, 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 is one drug master file entry for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

Summary for 215185

Tradename:	KETOCONAZOLE
Applicant:	Padagis Us
Ingredient:	ketoconazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 215185

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	2%
Approval Date:	Nov 17, 2021	TE:		RLD:	No

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