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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 075912

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NDA 075912 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 075912

Tradename:	KETOCONAZOLE
Applicant:	Senores Pharms
Ingredient:	ketoconazole
Patents:	0

Pharmacology for NDA: 075912

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

Medical Subject Heading (MeSH) Categories for 075912

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

Suppliers and Packaging for NDA: 075912

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETOCONAZOLE	ketoconazole	TABLET;ORAL	075912	ANDA	Burel Pharmaceuticals, LLC	35573-433	35573-433-02	100 TABLET in 1 BOTTLE (35573-433-02)
KETOCONAZOLE	ketoconazole	TABLET;ORAL	075912	ANDA	Burel Pharmaceuticals, LLC	35573-433	35573-433-30	30 TABLET in 1 BOTTLE (35573-433-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jan 10, 2002	TE:	AB	RLD:	No

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