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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 218498

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NDA 218498 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 218498

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

Pharmacology for NDA: 218498

Mechanism of Action	Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for 218498

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

Suppliers and Packaging for NDA: 218498

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETOCONAZOLE	ketoconazole	SHAMPOO;TOPICAL	218498	ANDA	ANI Pharmaceuticals, Inc.	70954-662	70954-662-10	120 mL in 1 BOTTLE, PLASTIC (70954-662-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SHAMPOO;TOPICAL			Strength	2%
Approval Date:	Sep 16, 2024	TE:	AB	RLD:	No

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