FDA.reportPublic FDA data

Application 761219

Type
BLA
Sponsor
CELLTRION

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761219Yuflymaadalimumab-aaty351(k) InterchangeableRx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001YUFLYMAADALIMUMAB-AATYINJECTABLE;INJECTION40MG/0.4MLNoNo

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 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YuflymaADALIMUMAB-AATYCELLTRION USA, Inc.526d626f-8c9f-496c-b838-00a73bb363832026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761219
AdalimumabADALIMUMAB-AATYCELLTRION USA, Inc.c44365e9-d470-4e35-978d-8565a9e3471e2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761219

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83874SUPPL 2025-10-22
83873SUPPL 2025-10-22
83806SUPPL 2025-10-20
82454SUPPL 2025-06-03
82305SUPPL 2025-05-23
82227SUPPL 2025-05-21
82216SUPPL 2025-05-21
81907SUPPL 2025-04-09
81840SUPPL 2025-04-08
80761SUPPL 2024-12-27
80756SUPPL 2024-12-27
79441SUPPL 2024-08-20
79435SUPPL 2024-08-19
77152SUPPL 2023-12-27
77149SUPPL 2023-12-27
77148SUPPL 2023-12-27
77139SUPPL 2023-12-27
77138SUPPL 2023-12-27
77137SUPPL 2023-12-27
76715SUPPL 2023-12-01
76707SUPPL 2023-12-01
74362ORIG 2023-10-03
75640SUPPL 2023-10-02
75568SUPPL 2023-09-26
75549SUPPL 2023-09-25
75371SUPPL 2023-09-07
75363SUPPL 2023-09-07
75042ORIG 2023-08-11
74359ORIG 2023-05-24