Last Updated: November 8, 2026

Details for New Drug Application (NDA): 219129

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NDA 219129 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 219129

Tradename:	KETOCONAZOLE
Applicant:	Novitium Pharma
Ingredient:	ketoconazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 219129

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jul 3, 2025	TE:	AB	RLD:	No

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