FDA.reportPublic FDA data

Application 213227

Type
NDA
Sponsor
RADIOMEDIX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DETECTNETCOPPER CU 64 DOTATATEINJECTABLE;INJECTION148 MBq (4 mCi) (37 MBq (1mCi) per 1ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69945-064Detectnetcopper Cu 64 DotatateCURIUM US LLCNDACurrent
69945-064Detectnetcopper Cu 64 DotatateCURIUM US LLCNDACurrent
69945-064Detectnetcopper Cu 64 DotatateCURIUM US LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69779SUPPL2021-12-27
69767SUPPL2021-12-27
64636ORIG2020-09-22
64584ORIG2020-09-16
64491ORIG2020-09-04