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Last Updated: June 23, 2024

Details for New Drug Application (NDA): 210457


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NDA 210457 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 210457
Tradename:KETOCONAZOLE
Applicant:Strides Pharma
Ingredient:ketoconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 210457
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOCONAZOLE ketoconazole TABLET;ORAL 210457 ANDA Strides Pharma Science Limited 64380-827 64380-827-06 100 TABLET in 1 BOTTLE (64380-827-06)
KETOCONAZOLE ketoconazole TABLET;ORAL 210457 ANDA Strides Pharma Science Limited 64380-827 64380-827-07 500 TABLET in 1 BOTTLE (64380-827-07)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jun 18, 2018TE:ABRLD:No

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