Home Applications 761285 Application 761285
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 761285 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 45MG/0.5ML No No 002 WEZLANA USTEKINUMAB-AUUB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 90MG/ML 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: BLA761285
Documents# Document, Submission type, Date table Document Submission type Date 85958 SUPPL 2026-05-19 85945 SUPPL 2026-05-18 85906 SUPPL 2026-05-13 83547 SUPPL 2025-09-26 83534 SUPPL 2025-09-26 80770 SUPPL 2024-12-27 80765 SUPPL 2024-12-27 77411 ORIG 2024-02-07 76879 ORIG 2023-12-18 76016 ORIG 2023-11-01