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)Rx2026-10-01

Application Products#

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 ยท 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