Home Applications 761331 Application 761331
Type BLA
Sponsor AMGEN INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761331 Wezlana ustekinumab-auub 351(k) Interchangeable Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 WEZLANA USTEKINUMAB-AUUB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 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 WEZLANA USTEKINUMAB-AUUB Nuvaila Limited a6c23978-09f0-4796-88f7-d0ce7e3ed04e 2026-06-03 Warnings, Adverse reactions Exact identifier application number: BLA761331
Documents# Document, Submission type, Date table Document Submission type Date 85959 SUPPL 2026-05-19 85946 SUPPL 2026-05-18 85907 SUPPL 2026-05-13 83549 SUPPL 2025-09-26 83548 SUPPL 2025-09-26 80771 SUPPL 2024-12-27 80767 SUPPL 2024-12-27 77412 ORIG 2024-02-07 76881 ORIG 2023-12-18 76019 ORIG 2023-11-01 76018 ORIG 2023-11-01