FDA.reportPublic FDA data

Application 212773

Type
ANDA
Sponsor
EUGIA PHARMA

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
59651-240Imatinib MesylateImatinib MesylateAurobindo Pharma LimitedANDACurrent
59651-240Imatinib MesylateImatinib MesylateAurobindo Pharma LimitedANDACurrent
59651-240Imatinib MesylateImatinib MesylateAurobindo Pharma LimitedANDACurrent
59651-240Imatinib MesylateImatinib MesylateAurobindo Pharma LimitedANDACurrent
59651-240Imatinib MesylateImatinib MesylateAurobindo Pharma LimitedANDACurrent
59651-241Imatinib MesylateImatinib MesylateAurobindo Pharma LimitedANDACurrent
59651-241Imatinib MesylateImatinib MesylateAurobindo Pharma LimitedANDACurrent
59651-241Imatinib MesylateImatinib MesylateAurobindo Pharma LimitedANDACurrent
59651-241Imatinib MesylateImatinib MesylateAurobindo Pharma LimitedANDACurrent
59651-241Imatinib MesylateImatinib MesylateAurobindo Pharma LimitedANDACurrent