FDA.reportPublic FDA data

Application 079157

Type
ANDA
Sponsor
PHARMALUCENCE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TECHNETIUM TC 99M SESTAMIBITECHNETIUM TC-99M SESTAMIBI KITINJECTABLE;INJECTION10-30mCiNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45567-0555Kit for the Preparation of Technetium Tc99m SestamibiTECHNETIUM TC-99M SESTAMIBIPharmalucence, Inc.ANDACurrent
45567-0555Kit for the Preparation of Technetium Tc99m SestamibiTECHNETIUM TC-99M SESTAMIBISun Pharmaceutical Industries, Inc.ANDACurrent
45567-0555Kit for the Preparation of Technetium Tc99m SestamibiTECHNETIUM TC-99M SESTAMIBIPharmalucence, Inc.ANDACurrent
45567-0555Kit for the Preparation of Technetium Tc99m SestamibiTECHNETIUM TC-99M SESTAMIBISun Pharmaceutical Industries, Inc.ANDACurrent
45567-0555Kit for the Preparation of Technetium Tc99m SestamibiTECHNETIUM TC-99M SESTAMIBIPharmalucence, Inc.ANDACurrent