FDA.reportPublic FDA data

Application 761073

Type
BLA
Sponsor
AMGEN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KANJINTITRASTUZUMAB-ANNSINJECTABLE;INJECTION420MGNoNo
002KANJINTITRASTUZUMAB-ANNSVIAL;SINGLE-DOSE150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-132Kanjintitrastuzumab-annsAmgen IncBLACurrent
55513-132Kanjintitrastuzumab-annsAmgen IncBLACurrent
55513-132Kanjintitrastuzumab-annsAmgen IncBLACurrent
55513-132Kanjintitrastuzumab-annsAmgen IncBLACurrent
55513-132Kanjintitrastuzumab-annsAmgen IncBLACurrent
55513-132Kanjintitrastuzumab-annsAmgen IncBLACurrent
55513-141Kanjintitrastuzumab-annsAmgen IncBLACurrent
55513-141Kanjintitrastuzumab-annsAmgen IncBLACurrent
55513-141Kanjintitrastuzumab-annsAmgen IncBLACurrent
55513-141Kanjintitrastuzumab-annsAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80729SUPPL 2024-12-26
80664SUPPL 2024-12-20
64970SUPPL2020-10-21
64965SUPPL2020-10-21
59373ORIG2019-07-18
59055ORIG2019-06-13
59053ORIG2019-06-13