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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 Pharms, Janssen Pharma, and Johnson And Johnson, and is included in five NDAs. It is available from three suppliers. 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-five suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

Summary for NDA: 019927

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

Pharmacology for NDA: 019927

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 10147-0750-4 120 mL in 1 BOTTLE (10147-0750-4)
NIZORAL
ketoconazole
SHAMPOO;TOPICAL 019927 NDA Janssen Pharmaceuticals, Inc. 50458-680 50458-680-08 120 mL in 1 BOTTLE (50458-680-08)

Summary for product number 001

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

Expired Orange Book 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;TOPICAL019927-001Aug 31, 19904,335,125► subscribe
Janssen Pharms
NIZORAL
ketoconazole
SHAMPOO;TOPICAL019927-001Aug 31, 19904,942,162► subscribe
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