Details for New Drug Application (NDA): 019084

✉ Email this page to a colleague

NDA 019084 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

Summary for 019084

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

Medical Subject Heading (MeSH) Categories for 019084

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 31, 1985	TE:		RLD:	Yes

Expired US Patents for NDA 019084

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharma	NIZORAL	ketoconazole	CREAM;TOPICAL	019084-001	Dec 31, 1985	4,942,162	⤷ Subscribe
Janssen Pharma	NIZORAL	ketoconazole	CREAM;TOPICAL	019084-001	Dec 31, 1985	4,335,125	⤷ Subscribe
>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. 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.