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Last Updated: November 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020310

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NDA 020310 describes NIZORAL A-D, which is a drug marketed by Kramer and is included in one NDA. It is available from two suppliers. Additional details are available on the NIZORAL A-D profile page.

The generic ingredient in NIZORAL A-D is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 020310
Tradename:NIZORAL A-D
Applicant:Kramer
Ingredient:ketoconazole
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020310
Suppliers and Packaging for NDA: 020310
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIZORAL A-D ketoconazole SHAMPOO;TOPICAL 020310 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-895 50580-895-04 1 BOTTLE in 1 CARTON (50580-895-04) > 125 mL in 1 BOTTLE
NIZORAL A-D ketoconazole SHAMPOO;TOPICAL 020310 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-895 50580-895-07 1 BOTTLE in 1 CARTON (50580-895-07) > 200 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SHAMPOO;TOPICALStrength1%
Approval Date:Oct 10, 1997TE:RLD:Yes

Expired US Patents for NDA 020310

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Kramer NIZORAL A-D ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997   Start Trial   Start Trial
Kramer NIZORAL A-D ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997   Start Trial   Start Trial
Kramer NIZORAL A-D ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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