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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 076419

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NDA 076419 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 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-one suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

Summary for 076419

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

Pharmacology for NDA: 076419

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

Medical Subject Heading (MeSH) Categories for 076419

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

Suppliers and Packaging for NDA: 076419

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETOCONAZOLE	ketoconazole	SHAMPOO;TOPICAL	076419	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-465	45802-465-64	120 mL in 1 BOTTLE (45802-465-64)
KETOCONAZOLE	ketoconazole	SHAMPOO;TOPICAL	076419	ANDA	Bryant Ranch Prepack	63629-8675	63629-8675-1	120 mL in 1 BOTTLE (63629-8675-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SHAMPOO;TOPICAL			Strength	2%
Approval Date:	Jan 7, 2004	TE:	AB	RLD:	No

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