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

NDC Listings For This Application#

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-99mCurium US LLCNDACurrent
69945-887Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE 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-99mCurium US LLCNDACurrent
69945-891Ultra-TechneKowTechnetium Tc-99mMALLINCKRODT NUCLEAR MEDICINE 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