FDA.reportPublic FDA data

Application 761425

Type
BLA
Sponsor
SAMSUNG BIOEPIS CO LTD

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761425Pyzchivaustekinumab-ttwe351(k) InterchangeableRx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PYZCHIVAUSTEKINUMAB-TTWEINJECTABLE;SUBCUTANEOUS130MG/26ML(5MG/ML)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
PYZCHIVAUSTEKINUMAB-TTWESANDOZ INCe8a14922-7902-4d9f-8ba5-d91dccffed292026-07-09Warnings, Adverse reactionsExact identifier
application number: BLA761425
USTEKINUMAB-TTWEUSTEKINUMAB-TTWEQuallent Pharmaceuticals Health LLC2b34392a-ecf6-41bd-8706-d4e9f0b25da82026-01-12Warnings, Adverse reactionsExact identifier
application number: BLA761425

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84232SUPPL 2025-11-19
84231SUPPL 2025-11-19
84224SUPPL 2025-11-19
83993ORIG 2025-10-30
83358SUPPL 2025-09-17
83177SUPPL 2025-08-25
82156ORIG 2025-08-22
78970ORIG 2025-08-22
82280ORIG 2025-04-30
81606SUPPL 2025-03-17
81593SUPPL 2025-03-17
80921ORIG 2025-02-05
80735SUPPL 2024-12-26
80718SUPPL 2024-12-26
78953ORIG 2024-07-08