Home Applications 761338 Application 761338
Type BLA
Sponsor CELLTRION, INC. Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761338 Steqeyma ustekinumab-stba 351(k) Interchangeable Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 STEQEYMA USTEKINUMAB-STBA INJECTABLE;SUBCUTANEOUS 45MG/0.5ML No No 002 STEQEYMA USTEKINUMAB-STBA INJECTABLE;SUBCUTANEOUS 90MG/ML No No 003 STEQEYMA USTEKINUMAB-STBA INJECTABLE;INTRAVENOUS 130MG/26ML No No
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Matched openFDA labels page 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join STEQEYMA USTEKINUMAB-STBA CELLTRION USA, Inc. 66085e17-e3f2-4196-8c81-87448e804b0c 2026-04-07 Warnings, Adverse reactions Exact identifier application number: BLA761338
Documents# Document, Submission type, Date table Document Submission type Date 84452 SUPPL 2025-12-18 84420 SUPPL 2025-12-15 83933 ORIG 2025-10-27 83932 ORIG 2025-10-27 82671 SUPPL 2025-06-27 82669 SUPPL 2025-06-27 82575 SUPPL 2025-06-13 82150 ORIG 2025-05-05 82123 SUPPL 2025-05-01 82273 ORIG 2025-04-30 82038 SUPPL 2025-04-29 80619 ORIG 2024-12-18 80612 ORIG 2024-12-18