FDA.reportPublic FDA data

Application 019044

Type
NDA
Sponsor
GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDIUM IN 111 OXYQUINOLINEINDIUM IN-111 OXYQUINOLINEINJECTABLE;INJECTION1mCi/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17156-021Indium in 111 OxyquinolineIndium In-111 OxyquinolineMedi-Physics Inc. dba GE Healthcare.NDACurrent
17156-021Indium in 111 OxyquinolineIndium In-111 OxyquinolineMedi-Physics Inc. dba GE Healthcare.NDACurrent
17156-021Indium in 111 OxyquinolineIndium In-111 OxyquinolineMedi-Physics Inc. dba GE Healthcare.NDACurrent
17156-021Indium in 111 OxyquinolineIndium In-111 OxyquinolineMedi-Physics Inc. dba GE Healthcare.NDACurrent
17156-021Indium in 111 OxyquinolineIndium In-111 OxyquinolineMedi-Physics Inc. dba GE Healthcare.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72876SUPPL2022-12-13
72871SUPPL2022-12-13
11424ORIG2014-11-18
40869SUPPL2012-03-27
40868SUPPL2012-03-27
40870SUPPL2011-02-15
40867SUPPL2011-02-15
40866SUPPL2011-02-15
40865SUPPL2011-02-15
40864SUPPL2011-02-15
40863SUPPL2011-02-15
20203SUPPL2011-02-15
20202SUPPL2011-02-15
20201SUPPL2011-02-15
20200SUPPL2011-02-15
20199SUPPL2011-02-15
1215SUPPL2002-09-19