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Last Updated: June 23, 2024

Details for New Drug Application (NDA): 215185

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NDA 215185 describes KETOCONAZOLE, which is a drug marketed by Padagis Israel, Xiromed, Encube, Fougera Pharms, Tasman Pharma, Teva, Tolmar, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Senores Pharms, Strides Pharma, Sun Pharm Industries, and Taro, and is included in seventeen NDAs. It is available from twenty-four 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 215185
Applicant:Tasman Pharma
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 215185
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOCONAZOLE ketoconazole CREAM;TOPICAL 215185 ANDA Tasman Pharma Inc. 72641-005 72641-005-15 1 TUBE in 1 CARTON (72641-005-15) / 15 g in 1 TUBE
KETOCONAZOLE ketoconazole CREAM;TOPICAL 215185 ANDA Tasman Pharma Inc. 72641-005 72641-005-30 1 TUBE in 1 CARTON (72641-005-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2%
Approval Date:Nov 17, 2021TE:ABRLD:No

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