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ACTIVE SUBSTANCE / INN

KETOCONAZOLE

Brand name(s): Ketoconazole Esteve (previously Ketoconazole HRA), XOLEGEL, NIZORAL ANTI-DANDRUFF, Ketoconazole AID-SCFM, EXTINA, NIZORAL, KETOCONAZOLE, KETOZOLE
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
OVER-THE-COUNTER
ANDA075273
NDA019084
ACTIVE SUBSTANCE
Ketoconazole
REGULATORS
FDA · EMA
SPONSORS / MAH
JANSSEN PHARMA, TEVA, Esteve Pharmaceuticals, S.A.
TOTAL APPLICATIONS
9
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
KETOCONAZOLEANDA076294FOUGERA PHARMSPrescription
NIZORALNDA019084JANSSEN PHARMADiscontinued
KETOCONAZOLEANDA075273TEVADiscontinued
NIZORAL ANTI-DANDRUFFNDA020310KRAMEROver-the-counter
EXTINANDA021738RISINGDiscontinued
XOLEGELNDA021946INA PHARMSDiscontinued
KETOZOLEANDA075638SUN PHARMA CANADAPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Ketoconazole Esteve (previously Ketoconazole HRA)Esteve Pharmaceuticals, S.A.Authorised18/11/2014Cushing Syndrome
Ketoconazole AID-SCFMAgenzia Industrie Difesa-Stabilimento Chimico Farmaceutico MilitareApplication withdrawnCushing Syndrome

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