FDA.reportPublic FDA data

Application 761324

Type
BLA
Sponsor
GENMAB US, INC.

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761324Epkinlyepcoritamab-bysp351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPKINLYEPCORITAMAB-BYSPINJECTABLE;SUBCUTANEOUS4MG/0.8MLNoNo
002EPKINLYEPCORITAMAB-BYSPINJECTABLE;SUBCUTANEOUS48MG/0.8MLNoNo

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
EPKINLYEPCORITAMAB-BYSPGenmab US, Inc.d7836711-b677-412d-bf2d-0f7c8444103a2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761324

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85608SUPPL 2026-03-31
85576SUPPL 2026-03-30
85575SUPPL 2026-03-30
84226SUPPL 2025-11-19
84225SUPPL 2025-11-19
84221SUPPL 2025-11-19
83347SUPPL 2025-09-12
83345SUPPL 2025-09-12
78910SUPPL 2024-06-27
78904SUPPL 2024-06-27
74382ORIG 2023-05-26
74341ORIG 2023-05-22
74339ORIG 2023-05-22