You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 018533

✉ Email this page to a colleague

NDA 018533 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 018533

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

Medical Subject Heading (MeSH) Categories for 018533

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 018533

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	NIZORAL	ketoconazole	TABLET;ORAL	018533-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.