FDA.reportPublic FDA data

Application 078806

Type
ANDA
Sponsor
JUBILANT DRAXIMAGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TECHNETIUM TC 99M SESTAMIBITECHNETIUM TC-99M SESTAMIBI KITINJECTABLE;INJECTIONN/ANoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45548-141TECHNETIUM TC 99M SESTAMIBITechnetium TC 99m SestamibiJubilant Draximage (USA) Inc.ANDACurrent
45548-141TECHNETIUM TC 99M SESTAMIBITechnetium TC 99m SestamibiJubilant Draximage (USA) Inc.ANDACurrent
45548-141TECHNETIUM TC 99M SESTAMIBITechnetium TC 99m SestamibiJubilant Draximage (USA) Inc.ANDACurrent
45548-141TECHNETIUM TC 99M SESTAMIBITechnetium TC 99m SestamibiJubilant Draximage (USA) Inc.ANDACurrent