FDA.reportPublic FDA data

Application 212135

Type
ANDA
Sponsor
QILU

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
67184-0532imatinib mesylateimatinib mesylateQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0532imatinib mesylateimatinib mesylateQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0533imatinib mesylateimatinib mesylateQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0533imatinib mesylateimatinib mesylateQilu Pharmaceutical Co., Ltd.ANDACurrent
72819-185imatinib mesylateimatinib mesylateArchis Pharma LLCANDACurrent
72819-186imatinib mesylateimatinib mesylateArchis Pharma LLCANDACurrent