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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076294

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NDA 076294 describes KETOCONAZOLE, which is a drug marketed by Perrigo Israel, Fougera Pharms, Teva, Perrigo New York, Tolmar, Aaipharma Llc, Apotex, Mylan, Pliva, Sun Pharm Industries, and Taro, and is included in thirteen NDAs. It is available from twenty-seven suppliers. Additional details are available on the KETOCONAZOLE profile page.

The generic ingredient in KETOCONAZOLE 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 076294

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 076294

Medical Subject Heading (MeSH) Categories for 076294

Suppliers and Packaging for NDA: 076294

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOCONAZOLE ketoconazole CREAM;TOPICAL 076294 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0099 0168-0099-30 1 TUBE in 1 CARTON (0168-0099-30) > 30 g in 1 TUBE
KETOCONAZOLE ketoconazole CREAM;TOPICAL 076294 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0099 0168-0099-60 1 TUBE in 1 CARTON (0168-0099-60) > 60 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2%
Approval Date:Apr 28, 2004TE:ABRLD:No


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