Application 761077

Type
BLA
Sponsor
AMGEN INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761077Aimovigerenumab-aooe351(a)Rx2026-07-01

Application Products#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AIMOVIGERENUMAB-AOOEAmgen, Incb998ed05-94b0-47fd-b28f-cddd1e128fd82026-07-14Warnings, Adverse reactionsExact identifier
application number: BLA761077
ndc (product): 55513-841
ndc (product): 55513-842
ndc (product): 55513-840
ndc (product): 55513-843

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

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