FDA.reportPublic FDA data

Application 075912

Type
ANDA
Sponsor
HAVIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOCONAZOLEKETOCONAZOLETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35573-433KETOCONAZOLEketoconazoleBurel Pharmaceuticals, Inc.ANDACurrent
35573-433KETOCONAZOLEketoconazoleBurel Pharmaceuticals, LLCANDACurrent
35573-433KETOCONAZOLEketoconazoleBurel Pharmaceuticals, Inc.ANDACurrent
50090-6142KETOCONAZOLEketoconazoleA-S Medication SolutionsANDACurrent
70518-2831KETOCONAZOLEketoconazoleREMEDYREPACK INC.ANDACurrent
70518-2831KETOCONAZOLEketoconazoleREMEDYREPACK INC.ANDACurrent
70518-2831KETOCONAZOLEketoconazoleREMEDYREPACK INC.ANDACurrent
71335-1849KETOCONAZOLEketoconazoleBryant Ranch PrepackANDACurrent
71337-035KETOCONAZOLEketoconazoleHavix Group Inc d-b-a Aavis PharmaceuticalsANDACurrent
71337-035KETOCONAZOLEketoconazoleHavix Group Inc d-b-a Aavis PharmaceuticalsANDACurrent
72189-180KETOCONAZOLEKETOCONAZOLEDirect RxANDACurrent