Home Applications 761419 Application 761419
Type BLA
Sponsor BIO-THERA SOLUTIONS LTD Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761419 Starjemza ustekinumab-hmny 351(k) Interchangeable Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 STARJEMZA USTEKINUMAB-HMNY INJECTABLE;SUBCUTANEOUS 45MG/0.5ML No No 002 STARJEMZA USTEKINUMAB-HMNY INJECTABLE;SUBCUTANEOUS 130MG/26ML No No 003 STARJEMZA USTEKINUMAB-HMNY INJECTABLE;SUBCUTANEOUS 90MG/ML No No
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 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Starjemza USTEKINUMAB-HMNY Hikma Pharmaceuticals USA Inc. 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 2025-10-24 Warnings, Adverse reactions Exact identifier application number: BLA761419
Documents# Document, Submission type, Date table Document Submission type Date 82406 ORIG 2025-06-02 82405 ORIG 2025-06-02 82319 ORIG 2025-05-27