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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202158-001RADIOGENIX SYSTEMTECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR30-1153mCi/GENERATORSOLUTION / INTRAVENOUS, INTRAVESICULAR, OPHTHALMICRLD2018-02-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N202158-001RADIOGENIX SYSTEM30-1153mCi/GENERATORSOLUTION / INTRAVENOUS, INTRAVESICULAR, OPHTHALMICRLD2018-02-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N202158-001RADIOGENIX SYSTEM30-1153mCi/GENERATORSOLUTION / INTRAVENOUS, INTRAVESICULAR, OPHTHALMICRLD2018-02-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N202158-001RADIOGENIX SYSTEM30-1153mCi/GENERATORSOLUTION / INTRAVENOUS, INTRAVESICULAR, OPHTHALMICRLD2018-02-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N202158-001RADIOGENIX SYSTEM30-1153mCi/GENERATORSOLUTION / INTRAVENOUS, INTRAVESICULAR, OPHTHALMICRLD2018-02-08a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

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