FDA.reportPublic FDA data

Application 017478

Type
NDA
Sponsor
LANTHEUS MEDCL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GALLIUM CITRATE GA 67GALLIUM CITRATE GA-67INJECTABLE;INJECTION2mCi/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11994-121GalliumGALLIUM CITRATE GA-67Lantheus Medical Imaging, Inc.NDACurrent
11994-121GalliumGALLIUM CITRATE GA-67Lantheus Medical Imaging, Inc.NDACurrent
11994-121GalliumGALLIUM CITRATE GA-67Lantheus Medical Imaging, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55131SUPPL2018-08-07
55123SUPPL2018-08-07
600SUPPL2011-10-26
11001SUPPL2011-10-25
13154SUPPL2004-03-10