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Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075581

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NDA 075581 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 075581
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 075581
Medical Subject Heading (MeSH) Categories for 075581
Suppliers and Packaging for NDA: 075581
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOCONAZOLE ketoconazole CREAM;TOPICAL 075581 ANDA G&W Laboratories, Inc. 0713-0671 N 0713-0671-60
KETOCONAZOLE ketoconazole CREAM;TOPICAL 075581 ANDA G&W Laboratories, Inc. 0713-0671 N 0713-0671-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2%
Approval Date:Apr 25, 2000TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
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Chinese Patent Office

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