Application 017771

Type
NDA
Sponsor
LANTHEUS MEDCL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TECHNELITETECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATORSOLUTION;INTRAVENOUS0.0083-2.7 CI/GENERATORNoNo
002TECHNELITETECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATORSOLUTION;INTRAVENOUS1-20 CI/GENERATORYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11994-090TechneLiteTechnetium Tc99m GeneratorLantheus Medical Imaging, Inc.NDACurrent
11994-090TechneLiteTechnetium Tc99m GeneratorLantheus Medical Imaging, Inc.NDACurrent
11994-090TechneLiteTechnetium Tc99m GeneratorLantheus Medical Imaging, Inc.NDACurrent
11994-091TechneLiteTechnetium Tc99m GeneratorLantheus Medical Imaging, Inc.NDACurrent
11994-091TechneLiteTechnetium Tc99m GeneratorLantheus Medical Imaging, Inc.NDACurrent
11994-091TechneLiteTechnetium Tc99m GeneratorLantheus Medical Imaging, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73276SUPPL2023-01-23
73266SUPPL2023-01-23
13899SUPPL2014-02-13
33343SUPPL2014-02-12