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Last Updated: May 24, 2022

Details for New Drug Application (NDA): 020310


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

The generic ingredient in NIZORAL ANTI-DANDRUFF is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 020310
Tradename:NIZORAL ANTI-DANDRUFF
Applicant:Kramer
Ingredient:ketoconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020310
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310 NDA Kramer Laboratories 55505-192 55505-192-33 1 BOTTLE in 1 CARTON (55505-192-33) > 125 mL in 1 BOTTLE
NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310 NDA Kramer Laboratories 55505-192 55505-192-40 1 BOTTLE in 1 CARTON (55505-192-40) > 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 ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997 See Plans and Pricing See Plans and Pricing
Kramer NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997 See Plans and Pricing See Plans and Pricing
Kramer NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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