Home Applications 761434 Application 761434
Type BLA
Sponsor OTSUKA PHARM CO LTD Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761434 Voyxact sibeprenlimab-szsi 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VOYXACT SIBEPRENLIMAB-SZSI INJECTABLE;INJECTION 400MG/2ML(200MG/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 VOYXACT SIBEPRENLIMAB Otsuka America Pharmaceutical, Inc. c8a93b32-0676-4704-86dc-cb65f425c6e5 2026-03-17 Warnings, Adverse reactions Exact identifier application number: BLA761434
Documents# Document, Submission type, Date table Document Submission type Date 84491 ORIG 2025-12-22 84330 ORIG 2025-11-28 84318 ORIG 2025-11-25