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)Rx2026-06-01

Application Products#

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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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