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Details for Generic Name: ketoconazole

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Ketoconazole is the generic ingredient in six branded drugs marketed by Delcor Asset Corp, Perrigo Israel, Fougera Pharms, Teva, Taro, Janssen Pharma, Aqua Pharms, Perrigo New York, Tolmar, Janssen Pharms, Johnson And Johnson, Aaipharma Llc, Apotex, Mutual Pharma, Mylan, and Pliva, and is included in twenty-one NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for ketoconazole. Six suppliers are listed for this compound.

Summary for Generic Name: ketoconazole

Drug Master File Entries: see list15
Suppliers: see list6
Therapeutic Class:Antifungals

Pharmacology for Ingredient: ketoconazole

Clinical Trials for: ketoconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mutual Pharma
TABLET;ORAL075314Jun 15, 1999DISCNNo<disabled><disabled>
CREAM;TOPICAL075638Dec 18, 2002RXNo<disabled><disabled>
Janssen Pharms
TABLET;ORAL018533Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Aqua Pharms
GEL;TOPICAL021946Jul 28, 2006RXYes8,232,276<disabled>Y<disabled>
TABLET;ORAL075362Jun 15, 1999DISCNNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:
Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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