FDA.reportPublic FDA data

Application 761118

Type
BLA
Sponsor
PFIZER INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761118Abriladaadalimumab-afzb351(k) InterchangeableRx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABRILADAADALIMUMAB-AFZBINJECTABLE;INJECTION40MG/0.8MLNoNo
002ABRILADAADALIMUMAB-AFZBINJECTABLE;INJECTION20MG/0.4MLNoNo
003ABRILADAADALIMUMAB-AFZBINJECTABLE;INJECTION10MG/0.2MLNoNo

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
ABRILADAADALIMUMAB-AFZBA-S Medication Solutions1602cfaf-9ddd-4eb6-b847-10a4eebcf5e52026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761118
ABRILADAADALIMUMAB-AFZBA-S Medication Solutions79943fe6-1249-4074-9aed-c53937820d0f2026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761118
ABRILADAADALIMUMAB-AFZBPfizer Laboratories Div Pfizer Inc5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761118

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84486SUPPL 2025-12-22
84464SUPPL 2025-12-19
78897SUPPL 2024-03-15
78896SUPPL 2024-03-15
75679SUPPL 2023-10-06
75678SUPPL 2023-10-06
75677SUPPL 2023-10-05
75132SUPPL 2023-08-18
75098SUPPL 2023-08-17
74496SUPPL 2023-06-15
74491SUPPL 2023-06-15
71689SUPPL2022-08-01
71688SUPPL2022-08-01
71674SUPPL2022-08-01
61712ORIG2020-01-28
60958ORIG2019-11-19
60860ORIG2019-11-18
60859ORIG2019-11-18