Last Updated: June 9, 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, 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 thirty-one 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-two 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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