FDA.reportPublic FDA data

Application 761333

Type
BLA
Sponsor
AMGEN INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761333Bkemveculizumab-aeeb351(k) InterchangeableRx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BKEMVECULIZUMAB-AEEBINJECTABLE;INJECTION300MG/30ML(10MG/ML)NoNo

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BKEMVECULIZUMAB-AEEBAmgen Inc002f9748-b0e8-4b6e-a38b-56930a8394912026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761333

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85593SUPPL 2026-03-30
84317SUPPL 2025-11-25
84316SUPPL 2025-11-25
84305SUPPL 2025-11-25
83386SUPPL 2025-09-18
82031SUPPL 2025-04-28
81108SUPPL 2025-02-06
80961ORIG 2025-02-05
78572ORIG 2025-02-04
79984SUPPL 2024-10-25
79974SUPPL 2024-10-24
79112ORIG 2024-07-18
78567ORIG 2024-05-28