FDA.reportPublic FDA data

Application 202158

Type
NDA
Sponsor
NORTHSTAR MEDICAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RADIOGENIX SYSTEMTECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATORSOLUTION;INTRAVENOUS, INTRAVESICULAR, OPHTHALMIC30-1153mCi/GENERATORYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71612-006RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-006RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-006RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-006RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-006RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-006RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical RadioisNDACurrent
71612-075RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-075RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-075RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-075RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-120RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-120RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-120RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-120RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-150RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-150RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-150RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-150RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-190RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-190RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-190RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent
71612-190RadioGenix SystemTechnetium Tc 99m GeneratorNorthStar Medical Radioisotopes, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68127SUPPL2021-07-20
68126SUPPL2021-07-20
66870SUPPL2021-03-25
61372ORIG2019-12-20
59517SUPPL2019-07-30
59495SUPPL2019-07-30
54327SUPPL2018-05-24
54312SUPPL2018-05-23
52926SUPPL2018-03-13
52896SUPPL2018-03-12
52542ORIG2018-02-09
52503ORIG2018-02-08