FDA.reportPublic FDA data

Application 761379

Type
BLA
Sponsor
FRESENIUS KABI USA

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761379Otulfiustekinumab-aauz351(k) InterchangeableRx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OTULFIUSTEKINUMAB-AAUZINJECTABLE;INJECTION45MG/0.5MLNoNo
002OTULFIUSTEKINUMAB-AAUZINJECTABLE;INJECTION90MG/1MLNoNo
003OTULFIUSTEKINUMAB-AAUZINJECTABLE;INJECTION130MG/26MLNoNo

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
USTEKINUMAB-AAUZUSTEKINUMAB-AAUZFresenius Kabi USA, LLCa6d75316-c9a7-49cf-83be-b7b6c6cecf7a2026-02-26Warnings, Adverse reactionsExact identifier
application number: BLA761379
OtulfiUSTEKINUMAB-AAUZFresenius Kabi USA, LLC853130e5-7406-4fd6-8138-ff21791959272026-02-16Warnings, Adverse reactionsExact identifier
application number: BLA761379

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84811SUPPL 2026-01-21
84810SUPPL 2026-01-21
84778SUPPL 2026-01-20
83114SUPPL 2025-08-18
83113SUPPL 2025-08-18
83112SUPPL 2025-08-18
83104SUPPL 2025-08-18
82482ORIG 2025-06-09
82167ORIG 2025-05-08
82157ORIG 2025-05-05
82139SUPPL 2025-05-05
82271SUPPL 2025-04-30
82269ORIG 2025-04-30
82006SUPPL 2025-04-25
81949SUPPL 2025-04-21
81776SUPPL 2025-03-28
81722SUPPL 2025-03-25
81306SUPPL 2025-02-21
81297SUPPL 2025-02-20
79775ORIG 2024-09-30
79761ORIG 2024-09-30