Home Applications 761358 Application 761358
Type BLA
Sponsor CELLTRION Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761358 Zymfentra infliximab-dyyb 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZYMFENTRA INFLIXIMAB-DYYB INJECTABLE;INJECTION 120MG/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 ZYMFENTRA INFLIXIMAB-DYYB CELLTRION USA Inc. 93a193ab-9f96-4da6-aa7c-31212e81879a 2025-05-28 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761358
Documents# Document, Submission type, Date table Document Submission type Date 80000 ORIG 2024-10-28 78159 SUPPL 2024-04-19 78158 SUPPL 2024-04-19 75915 ORIG 2023-10-24 75914 ORIG 2023-10-24 75899 ORIG 2023-10-24