Home Applications 761365 Application 761365
Type BLA
Sponsor ASTELLAS Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761365 Vyloy zolbetuximab-clzb 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VYLOY ZOLBETUXIMAB-CLZB INJECTABLE;INJECTION 100MG 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 VYLOY ZOLBETUXIMAB Astellas Pharma US, Inc. e7695a21-abb6-47ac-93f8-0ece5a9c4409 2025-06-12 Warnings, Adverse reactions Exact identifier application number: BLA761365
Documents# Document, Submission type, Date table Document Submission type Date 82509 SUPPL 2025-06-09 82492 SUPPL 2025-06-09 80234 ORIG 2024-11-18 79924 ORIG 2024-10-21 79913 ORIG 2024-10-18