FDA.reportPublic FDA data

Application 125522

Type
BLA
Sponsor
AMGEN INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125522Repathaevolocumab351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REPATHAEVOLOCUMABINJECTABLE;INJECTION140MG/MLYesNo

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
REPATHAEVOLOCUMABAmgen USA Inc.cd61e902-166d-4aa6-9f3c-a18c1008d07e2026-07-16Warnings, Adverse reactionsExact identifier
application number: BLA125522
ndc (product): 72511-770
ndc (product): 72511-750
ndc (product): 72511-760

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 72 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-750REPATHAEvolocumabAmgen IncBLACurrent
55513-750REPATHAEvolocumabAmgen IncBLACurrent
55513-750REPATHAEvolocumabAmgen IncBLACurrent
55513-750REPATHAEvolocumabAmgen IncBLACurrent
55513-750REPATHAEvolocumabAmgen IncBLACurrent
55513-750REPATHAEvolocumabAmgen IncBLACurrent
55513-750REPATHAEvolocumabAmgen IncBLACurrent
55513-750REPATHAEvolocumabAmgen IncBLACurrent
55513-750REPATHAEvolocumabAmgen IncBLACurrent
55513-750REPATHAEvolocumabAmgen IncBLACurrent
55513-750REPATHAEvolocumabAmgen IncBLACurrent
55513-750REPATHAEvolocumabAmgen IncBLACurrent
55513-760REPATHAEvolocumabAmgen IncBLACurrent
55513-760REPATHAEvolocumabAmgen IncBLACurrent
55513-760REPATHAEvolocumabAmgen IncBLACurrent
55513-760REPATHAEvolocumabAmgen IncBLACurrent
55513-760REPATHAEvolocumabAmgen IncBLACurrent
55513-760REPATHAEvolocumabAmgen IncBLACurrent
55513-760REPATHAEvolocumabAmgen IncBLACurrent
55513-760REPATHAEvolocumabAmgen IncBLACurrent
55513-760REPATHAEvolocumabAmgen IncBLACurrent
55513-760REPATHAEvolocumabAmgen IncBLACurrent
55513-760REPATHAEvolocumabAmgen IncBLACurrent
55513-760REPATHAEvolocumabAmgen IncBLACurrent
55513-770REPATHAEvolocumabAmgen IncBLACurrent
55513-770REPATHAEvolocumabAmgen IncBLACurrent
55513-770REPATHAEvolocumabAmgen IncBLACurrent
55513-770REPATHAEvolocumabAmgen IncBLACurrent
55513-770REPATHAEvolocumabAmgen IncBLACurrent
55513-770REPATHAEvolocumabAmgen IncBLACurrent
55513-770REPATHAEvolocumabAmgen IncBLACurrent
55513-770REPATHAEvolocumabAmgen IncBLACurrent
55513-770REPATHAEvolocumabAmgen IncBLACurrent
55513-770REPATHAEvolocumabAmgen IncBLACurrent
55513-770REPATHAEvolocumabAmgen IncBLACurrent
55513-770REPATHAEvolocumabAmgen IncBLACurrent
72511-750REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-750REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-750REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-750REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-750REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-750REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-750REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-750REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-750REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-750REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-750REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-750REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-760REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-760REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-760REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-760REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-760REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-760REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-760REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-760REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-760REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-760REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-760REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-760REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-770REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-770REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-770REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-770REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-770REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-770REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-770REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-770REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-770REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-770REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-770REPATHAEvolocumabAmgen USA Inc.BLACurrent
72511-770REPATHAEvolocumabAmgen USA Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84044SUPPL 2025-11-19
83190SUPPL 2025-08-25
83174SUPPL 2025-08-22
80267SUPPL 2024-11-21
80262SUPPL 2024-11-21
79460SUPPL 2024-08-22
79455SUPPL 2024-08-21
71839SUPPL2022-08-17
71813SUPPL2022-08-17
68800ORIG2021-09-29
68791SUPPL2021-09-28
68790SUPPL2021-09-28
68785SUPPL2021-09-24
66443ORIG2021-03-02
66434ORIG2021-03-01
62964SUPPL2020-05-13
58298SUPPL2019-04-12
57825SUPPL2019-02-27
57727SUPPL2019-02-27
57728SUPPL2019-02-21
57703SUPPL2019-02-19
56131SUPPL2018-10-29
56097SUPPL2018-10-26
50597SUPPL2017-12-04
50596SUPPL2017-12-04
50595SUPPL2017-12-04
50594SUPPL2017-12-04
48432SUPPL2017-05-17
48431SUPPL2017-05-17
46999SUPPL2017-01-27
46973SUPPL2017-01-25
46670SUPPL2017-01-05
46662SUPPL2017-01-04
46036SUPPL2016-12-06
45990SUPPL2016-12-01
9778SUPPL2016-07-12
9777SUPPL2016-07-12
44816ORIG2015-10-01
22820ORIG2015-10-01
31991ORIG2015-09-01
39987ORIG2015-08-28