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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 070767

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NDA 070767 describes NIZORAL, which is a drug marketed by Janssen Pharma, Janssen Pharms, and Kramer, and is included in five NDAs. Additional details are available on the NIZORAL profile page.

The generic ingredient in NIZORAL 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 070767

Tradename:	NIZORAL
Applicant:	Janssen Pharma
Ingredient:	ketoconazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 070767

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	100MG/5ML
Approval Date:	Nov 7, 1986	TE:		RLD:	No

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