Application 018321

Type
NDA
Sponsor
CURIUM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TECHNESCANTECHNETIUM TC-99M OXIDRONATE KITINJECTABLE;INJECTIONN/AYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69945-091Technescan HDPTechnetium Tc 99m OxidronateCurium US LLCNDACurrent
69945-091Technescan HDPTechnetium Tc 99m OxidronateCurium US LLCNDACurrent
69945-091Technescan HDPTechnetium Tc 99m OxidronateCurium US LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84314SUPPL 2025-11-25
84308SUPPL 2025-11-25
82438SUPPL 2025-06-03
82323SUPPL 2025-05-27
47854SUPPL2017-04-04
47818SUPPL2017-04-03