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Last Updated: July 3, 2020

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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. It is available from one supplier. 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-four 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
Suppliers and Packaging for NDA: 019927
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIZORAL ketoconazole SHAMPOO;TOPICAL 019927 NDA AUTHORIZED GENERIC Patriot Pharmaceuticals, LLC 10147-0750 10147-0750-5 1 BOTTLE in 1 BOX (10147-0750-5) > 120 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SHAMPOO;TOPICALStrength2%
Approval Date:Aug 31, 1990TE:ABRLD:Yes

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