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Generated: January 16, 2019

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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-two suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 075638
Tradename:KETOZOLE
Applicant:Taro
Ingredient:ketoconazole
Patents:0
Formulation / Manufacturing:see details
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 21695-554-15 1 TUBE in 1 CARTON (21695-554-15) > 15 g in 1 TUBE
KETOZOLE ketoconazole CREAM;TOPICAL 075638 ANDA Rebel Distributors Corp 21695-555 21695-555-30 1 TUBE in 1 CARTON (21695-555-30) > 30 g in 1 TUBE

Profile for product number 001

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

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