Home Applications 761339 Application 761339
Type BLA
Sponsor REGENERON PHARMACEUTICALS Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761339 Veopoz pozelimab-bbfg 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VEOPOZ POZELIMAB-BBFG 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 VEOPOZ POZELIMAB Regeneron Pharmaceuticals, Inc. a8d6f10e-9430-450a-a3dd-b538f9b2a308 2025-12-04 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761339
Documents# Document, Submission type, Date table Document Submission type Date 75517 ORIG 2023-09-20 75296 ORIG 2023-08-25 75149 ORIG 2023-08-21 75128 ORIG 2023-08-19