FDA.reportPublic FDA data

Application 204285

Type
ANDA
Sponsor
TEVA PHARMS USA

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
0093-7629Imatinib MesylateImatinib MesylateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7629Imatinib MesylateImatinib MesylateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7629Imatinib MesylateImatinib MesylateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7629Imatinib MesylateImatinib MesylateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7629Imatinib MesylateImatinib MesylateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7630Imatinib MesylateImatinib MesylateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7630Imatinib MesylateImatinib MesylateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7630Imatinib MesylateImatinib MesylateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7630Imatinib MesylateImatinib MesylateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7630Imatinib MesylateImatinib MesylateTeva Pharmaceuticals USA, Inc.ANDACurrent
60429-925Imatinib MesylateImatinib MesylateGSMS, IncorporatedANDACurrent
60429-925Imatinib MesylateImatinib MesylateGolden State Medical Supply, Inc.ANDACurrent
60429-926Imatinib MesylateImatinib MesylateGSMS, IncorporatedANDACurrent
60429-926Imatinib MesylateImatinib MesylateGolden State Medical Supply, Inc.ANDACurrent