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Serving leading biopharmaceutical companies globally:

Queensland Health
Daiichi Sankyo
Johnson and Johnson
US Army

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075638

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NDA 075638 describes KETOZOLE, which is a drug marketed by Taro and is included in one NDA. It is available from nine suppliers. Additional details are available on the KETOZOLE profile page.

The generic ingredient in KETOZOLE 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 075638
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 075638
Medical Subject Heading (MeSH) Categories for 075638
Suppliers and Packaging for NDA: 075638
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOZOLE ketoconazole CREAM;TOPICAL 075638 ANDA Rebel Distributors Corp 21695-554 E 21695-554-15
KETOZOLE ketoconazole CREAM;TOPICAL 075638 ANDA Rebel Distributors Corp 21695-555 E 21695-555-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2%
Approval Date:Dec 18, 2002TE:ABRLD:No

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Harvard Business School
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Federal Trade Commission
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Argus Health

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