FDA.reportPublic FDA data

Application 208302

Type
ANDA
Sponsor
SHILPA MEDICARE LTD

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
59923-723Imatinib MesylateImatinib MesylateAreva PharmaceuticalsANDACurrent
59923-723Imatinib MesylateImatinib MesylateAreva PharmaceuticalsANDACurrent
59923-724Imatinib MesylateImatinib MesylateAreva PharmaceuticalsANDACurrent
59923-724Imatinib MesylateImatinib MesylateAreva PharmaceuticalsANDACurrent
67877-633Imatinib mesylateimatinib mesylateAscend Laboratories, LLCANDACurrent
67877-634Imatinib mesylateimatinib mesylateAscend Laboratories, LLCANDACurrent
72485-202Imatinib mesylateimatinib mesylateArmas Pharmaceuticals Inc.ANDACurrent
72485-203Imatinib mesylateimatinib mesylateArmas Pharmaceuticals Inc.ANDACurrent
72606-556Imatinib mesylateimatinib mesylateCELLTRION USA, INC.ANDACurrent
72606-557Imatinib mesylateimatinib mesylateCELLTRION USA, INC.ANDACurrent