Details for New Drug Application (NDA): 019927

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NDA 019927 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-seven suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

Summary for 019927

Tradename:	NIZORAL
Applicant:	Janssen Pharms
Ingredient:	ketoconazole
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 019927

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SHAMPOO;TOPICAL			Strength	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 31, 1990	TE:		RLD:	Yes

Expired US Patents for NDA 019927

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	NIZORAL	ketoconazole	SHAMPOO;TOPICAL	019927-001	Aug 31, 1990	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	NIZORAL	ketoconazole	SHAMPOO;TOPICAL	019927-001	Aug 31, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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