FDA.reportPublic FDA data

Application 208700

Type
NDA
Sponsor
AAA USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUTATHERALUTETIUM DOTATATE LU-177SOLUTION;INTRAVENOUS10mCi/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69488-003LutatheraLutetium Lu 177 dotatateAdvanced Accelerator Applications USA, IncNDACurrent
69488-003LutatheraLutetium Lu 177 dotatateAdvanced Accelerator Applications USA, IncNDACurrent
69488-003LutatheraLutetium Lu 177 dotatateAdvanced Accelerator Applications USA, IncNDACurrent
69488-003LutatheraLutetium Lu 177 dotatateAdvanced Accelerator Applications USA, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80509SUPPL 2024-12-05
80497SUPPL 2024-12-04
78223SUPPL 2024-04-23
73710SUPPL 2023-03-08
73707SUPPL 2023-03-08
71334SUPPL2022-06-16
71332SUPPL2022-06-15
71302SUPPL2022-06-14
71301SUPPL2022-06-14
71240SUPPL2022-06-07
63362SUPPL2020-06-01
63350SUPPL2020-05-29
52916ORIG2018-03-12
51797ORIG2018-01-26
51796ORIG2018-01-26