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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
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Harvard Business School
Daiichi Sankyo
Express Scripts

Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075597

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NDA 075597 describes KETOCONAZOLE, which is a drug marketed by Apotex, Sun Pharm Inds, Perrigo New York, Taro, Aaipharma Llc, Tolmar, Perrigo Israel, Pliva, Teva, Fougera Pharms, and Mylan, 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 NDA: 075597

Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 075597

Suppliers and Packaging for NDA: 075597

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 075597 ANDA KAISER FOUNDATION HOSPITALS 0179-0055 0179-0055-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0055-70)
TABLET;ORAL 075597 ANDA Mylan Pharmaceuticals Inc. 0378-0261 0378-0261-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0261-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 23, 1999TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Fish and Richardson
Daiichi Sankyo
Johnson and Johnson
Queensland Health
Federal Trade Commission

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