FDA.reportPublic FDA data

Application 761255

Type
BLA
Sponsor
FRESENIUS KABI USA

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761255Idacioadalimumab-aacf351(k) BiosimilarRx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IDACIOADALIMUMAB-AACFINJECTABLE;SUBCUTANEOUS40MG/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 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IdacioADALIMUMAB-AACFFresenius Kabi USA, LLC43de75ac-1a37-4609-9edd-68bda2448a472026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761255
Adalimumab-aacfADALIMUMABFresenius Kabi USA, LLC2488b0bc-7b8f-4cc8-91ea-48e7ea5e89152026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761255
IDACIOADALIMUMAB-AACFFresenius Kabi USA, LLC08dbaffe-9d05-43cf-b24b-b44ade8685fc2024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761255

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84713SUPPL 2026-01-06
84623SUPPL 2025-12-31
80648SUPPL 2024-12-19
80628SUPPL 2024-12-19
80627SUPPL 2024-12-19
78630SUPPL 2024-07-02
77193ORIG 2024-07-02
78653SUPPL 2024-06-05
78552ORIG 2024-05-24
77251ORIG 2024-01-22
76629SUPPL 2023-11-17
76599SUPPL 2023-11-17
76032SUPPL 2023-11-02
76024SUPPL 2023-11-01
75723SUPPL 2023-10-16
75709SUPPL 2023-10-12
73419ORIG 2023-02-09
72884ORIG2022-12-15
72882ORIG2022-12-14