FDA.reportPublic FDA data

Application 017243

Type
NDA
Sponsor
CURIUM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002ULTRA-TECHNEKOW FMTECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATORSOLUTION;INTRAVENOUS0.25-3 CI/GENERATORNoNo
003ULTRA-TECHNEKOW FMTECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATORSOLUTION;INTRAVENOUS1-19 CI/GENERATORYesYes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017243-002ULTRA-TECHNEKOW V4TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 1982
N017243-003ULTRA-TECHNEKOW V4TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-18

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017243-002ULTRA-TECHNEKOW V40.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017243-003ULTRA-TECHNEKOW V41-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-18a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra-Technekow V4TECHNETIUM TC-99MCurium US LLC98947d99-5be5-461e-ad36-7425d36463892024-10-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 017243
application number: NDA017243
ndc (product): 69945-140
ndc (product): 69945-030
ndc (product): 69945-060
ndc (product): 69945-010
ndc (product): 69945-075
ndc (product): 69945-051
ndc (product): 69945-160
ndc (product): 69945-190
ndc (product): 69945-025
ndc (product): 69945-110
ndc (product): 69945-020
ndc (product): 69945-035
ndc (product): 69945-015

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 · 64 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69945-010Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-010Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-010Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-015Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-015Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-015Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-020Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-020Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-020Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-025Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-025Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-025Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-030Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-030Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-030Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-035Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-035Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-035Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-051Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-051Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-051Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-060Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-060Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-060Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-075Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-075Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-075Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-110Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-110Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-110Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-140Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-140Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-140Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-160Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-160Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-160Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-190Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-190Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-190Ultra-TechnekowTechnetium Tc-99mCurium US LLCNDACurrent
69945-883Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE LLCNDACurrent
69945-884Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE LLCNDACurrent
69945-884Ultra-TechneKowTechnetium Tc-99mCurium US LLCNDACurrent
69945-885Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE LLCNDACurrent
69945-885Ultra-TechneKowTechnetium Tc-99mCurium US LLCNDACurrent
69945-886Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE LLCNDACurrent
69945-886Ultra-TechneKowTechnetium Tc-99mCurium US LLCNDACurrent
69945-887Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE LLCNDACurrent
69945-887Ultra-TechneKowTechnetium Tc-99mCurium US LLCNDACurrent
69945-888Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE LLCNDACurrent
69945-888Ultra-TechneKowTechnetium Tc-99mCurium US LLCNDACurrent
69945-889Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE LLCNDACurrent
69945-889Ultra-TechneKowTechnetium Tc-99mCurium US LLCNDACurrent
69945-890Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE LLCNDACurrent
69945-890Ultra-TechneKowTechnetium Tc-99mCurium US LLCNDACurrent
69945-891Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE LLCNDACurrent
69945-891Ultra-TechneKowTechnetium Tc-99mCurium US LLCNDACurrent
69945-892Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE LLCNDACurrent
69945-892Ultra-TechneKowTechnetium Tc-99mCurium US LLCNDACurrent
69945-893Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE LLCNDACurrent
69945-893Ultra-TechneKowTechnetium Tc-99mCurium US LLCNDACurrent
69945-894Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE LLCNDACurrent
69945-894Ultra-TechneKowTechnetium Tc-99mCurium US LLCNDACurrent
69945-895Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE LLCNDACurrent
69945-895Ultra-TechneKowTechnetium Tc-99mCurium US LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33239SUPPL2015-05-06
560SUPPL2015-05-05
33237SUPPL2014-02-19
13103SUPPL2014-02-19
33238SUPPL2014-01-13
559SUPPL2013-12-24
13102SUPPL2006-04-05
10973SUPPL2004-10-22
558SUPPL2004-10-22
557SUPPL2004-06-29