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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
US Department of Justice
Citi
Cerilliant
Accenture
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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076942

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NDA 076942 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-eight 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-six suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 076942
Tradename:KETOCONAZOLE
Applicant:Tolmar
Ingredient:ketoconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 076942
Medical Subject Heading (MeSH) Categories for 076942
Suppliers and Packaging for NDA: 076942
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOCONAZOLE ketoconazole SHAMPOO;TOPICAL 076942 ANDA Sandoz Inc. 0781-7090 0781-7090-04 118.28 mL in 1 BOTTLE, PLASTIC (0781-7090-04)
KETOCONAZOLE ketoconazole SHAMPOO;TOPICAL 076942 ANDA TOLMAR Inc. 63646-010 63646-010-04 118.28 mL in 1 BOTTLE, PLASTIC (63646-010-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SHAMPOO;TOPICALStrength2%
Approval Date:Apr 11, 2005TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Chinese Patent Office
Daiichi Sankyo
AstraZeneca
Fish and Richardson
QuintilesIMS
Argus Health
Covington
US Army

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