FDA.reportPublic FDA data

Application 208429

Type
ANDA
Sponsor
WOCKHARDT BIO AG

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
64679-793Imatinib Mesylateimatinib mesylateWockhardt USA LLC.ANDACurrent
64679-793Imatinib Mesylateimatinib mesylateWockhardt USA LLC.ANDACurrent
64679-794Imatinib Mesylateimatinib mesylateWockhardt USA LLC.ANDACurrent
64679-794Imatinib Mesylateimatinib mesylateWockhardt USA LLC.ANDACurrent