FDA.reportPublic FDA data

Application 207586

Type
ANDA
Sponsor
HIKMA

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
0054-0248Imatinib MesylateImatinib MesylateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0248Imatinib MesylateImatinib MesylateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0248Imatinib MesylateImatinib MesylateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0248Imatinib MesylateImatinib MesylateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0249Imatinib MesylateImatinib MesylateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0249Imatinib MesylateImatinib MesylateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0249Imatinib MesylateImatinib MesylateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0249Imatinib MesylateImatinib MesylateWest-Ward Pharmaceuticals CorpANDACurrent