FDA.reportPublic FDA data

Application 205990

Type
ANDA
Sponsor
BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMATINIB MESYLATEIMATINIB MESYLATETABLET;ORALEQ 100MG BASENoNo
002IMATINIB MESYLATEIMATINIB MESYLATETABLET;ORALEQ 400MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51991-376IMATINIB MESYLATEIMATINIB MESYLATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-376IMATINIB MESYLATEIMATINIB MESYLATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-376IMATINIB MESYLATEIMATINIB MESYLATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-376IMATINIB MESYLATEIMATINIB MESYLATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-376IMATINIB MESYLATEIMATINIB MESYLATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-377IMATINIB MESYLATEIMATINIB MESYLATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-377IMATINIB MESYLATEIMATINIB MESYLATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-377IMATINIB MESYLATEIMATINIB MESYLATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-377IMATINIB MESYLATEIMATINIB MESYLATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-377IMATINIB MESYLATEIMATINIB MESYLATEBreckenridge Pharmaceutical, Inc.ANDACurrent
63629-2067IMATINIB MESYLATEIMATINIB MESYLATEBryant Ranch PrepackANDACurrent
63629-2067IMATINIB MESYLATEIMATINIB MESYLATEBryant Ranch PrepackANDACurrent
63629-2067IMATINIB MESYLATEIMATINIB MESYLATEBryant Ranch PrepackANDACurrent
63629-2068IMATINIB MESYLATEIMATINIB MESYLATEBryant Ranch PrepackANDACurrent
63629-2068IMATINIB MESYLATEIMATINIB MESYLATEBryant Ranch PrepackANDACurrent
63629-2068IMATINIB MESYLATEIMATINIB MESYLATEBryant Ranch PrepackANDACurrent