FDA.reportPublic FDA data

Application 210828

Type
NDA
Sponsor
UIHC PET IMAGING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GALLIUM DOTATOC GA 68GALLIUM DOTATOC GA-68SOLUTION;INTRAVENOUS0.5-4mCi/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24417-681Ga-68-DOTATOCEDOTREOTIDE GALLIUM GA-68UIHC NDACurrent
24417-681Ga-68-DOTATOCEDOTREOTIDE GALLIUM GA-68UIHC NDACurrent
24417-681Ga-68-DOTATOCEDOTREOTIDE GALLIUM GA-68UIHC NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74953SUPPL 2023-07-31
74930SUPPL 2023-07-31
69780SUPPL2021-12-27
69766SUPPL2021-12-27
60084ORIG2019-09-23
59782ORIG2019-09-16
59810ORIG2019-08-22