FDA.reportPublic FDA data

Application 761275

Type
BLA
Sponsor
FRESENIUS KABI USA

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761275Tyennetocilizumab-aazg351(k) BiosimilarRx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002TYENNETOCILIZUMAB-AAZGINJECTABLE;INTRAVENOUS80MG/4MLNoNo
003TYENNETOCILIZUMAB-AAZGINJECTABLE;INTRAVENOUS200MG/10MLNoNo
004TYENNETOCILIZUMAB-AAZGINJECTABLE;INTRAVENOUS400MG/20ML NoNo

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
TYENNETOCILIZUMAB-AAZGFresenius Kabi USA, LLCad76441d-da59-47df-8d9d-2243005180f02026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761275
TYENNETOCILIZUMAB-AAZGFresenius Kabi USA, LLCe400bbe6-43c5-4de6-82b9-cb44ce3cd9062026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761275

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
86013SUPPL 2026-05-22
86008SUPPL 2026-05-21
86003SUPPL 2026-05-21
84825SUPPL 2026-01-22
84819SUPPL 2026-01-22
82179SUPPL 2025-05-14
82248SUPPL 2025-05-12
82247SUPPL 2025-05-12
81598SUPPL 2025-03-17
81431SUPPL 2025-03-04
81388SUPPL 2025-03-03
80591SUPPL 2024-12-16
80582SUPPL 2024-12-16
80525SUPPL 2024-12-05
80504SUPPL 2024-12-04
79566SUPPL 2024-09-09
78878ORIG 2024-06-24
77736ORIG 2024-03-08
77754ORIG 2024-03-07