ACTIVE SUBSTANCE / INN

ITRACONAZOLE

Brand name(s): TOLSURA, SPORANOX, ONMEL, ITRACONAZOLE
FDA LISTED
PRESCRIPTION
DISCONTINUED
NDA022484
ANDA208481
ACTIVE SUBSTANCE
Itraconazole
REGULATORS
FDA
SPONSORS / MAH
SEBELA IRELAND LTD, AMNEAL PHARMS, APOTEX
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ITRACONAZOLEANDA208481APOTEXDiscontinued
SPORANOXNDA020657JANSSEN PHARMSDiscontinued
ITRACONAZOLEANDA205080AMNEAL PHARMSPrescription
SPORANOXNDA020083JANSSEN PHARMSPrescription
TOLSURANDA208901MAYNE PHARMAPrescription
ONMELNDA022484SEBELA IRELAND LTDDiscontinued

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