FDA.reportPublic FDA data

Application 761077

Type
BLA
Sponsor
AMGEN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AIMOVIGERENUMAB-AOOEINJECTABLE;INJECTION70MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-840AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-840AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-840AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-840AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-840AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-840AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-840AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-840AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-840AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-840AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-840AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-840AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-841AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-841AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-841AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-841AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-841AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-841AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-841AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-841AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-841AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-841AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-841AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-841AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-842AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-842AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-842AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-842AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-842AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-842AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-842AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-842AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-842AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-842AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-842AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-842AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-843AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-843AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-843AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-843AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-843AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-843AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-843AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-843AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-843AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-843AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-843AIMOVIGerenumab-aooeAmgen IncBLACurrent
55513-843AIMOVIGerenumab-aooeAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82625SUPPL 2025-06-20
82601SUPPL 2025-06-20
81720SUPPL 2025-03-25
81694SUPPL 2025-03-24
79338SUPPL 2024-08-08
79335SUPPL 2024-08-08
72265SUPPL2022-10-07
72241SUPPL2022-10-04
72150SUPPL2022-09-23
72147SUPPL2022-09-23
71811SUPPL2022-08-16
70503SUPPL2022-03-14
67470SUPPL2021-05-12
67455SUPPL2021-05-12
66096SUPPL2021-02-05
66088SUPPL2021-02-04
62801SUPPL2020-05-01
62794SUPPL2020-05-01
61921SUPPL2020-02-20
61913SUPPL2020-02-19
60306SUPPL2019-10-08
60260SUPPL2019-10-07
57976SUPPL2019-03-12
57968SUPPL2019-03-12
54606ORIG2018-06-14
54248ORIG2018-05-18
54247ORIG2018-05-18