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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 075319


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NDA 075319 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, Rise Pharma, 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 075319
Tradename:KETOCONAZOLE
Applicant:Taro
Ingredient:ketoconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075319
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOCONAZOLE ketoconazole TABLET;ORAL 075319 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4026 51672-4026-0 10 BLISTER PACK in 1 BOX (51672-4026-0) / 10 TABLET in 1 BLISTER PACK
KETOCONAZOLE ketoconazole TABLET;ORAL 075319 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4026 51672-4026-1 100 TABLET in 1 BOTTLE (51672-4026-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jun 15, 1999TE:ABRLD:No

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