FDA.reportPublic FDA data

Application 078098

Type
ANDA
Sponsor
CURIUM

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
69945-092Technetium Tc 99m SestamibiTechnetium Tc 99m SestamibiCurium US LLCANDACurrent
69945-092Technetium Tc 99m SestamibiTechnetium Tc 99m SestamibiCurium US LLCANDACurrent
69945-092Technetium Tc 99m SestamibiTechnetium Tc 99m SestamibiCurium US LLCANDACurrent
69945-092Technetium Tc 99m SestamibiTechnetium Tc 99m SestamibiCurium US LLCANDACurrent
69945-092Technetium Tc 99m SestamibiTechnetium Tc 99m SestamibiCurium US LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22620ORIG2012-03-28
31331ORIG2008-09-23