Home Applications 125544 Application 125544
Type BLA
Sponsor CELLTRION INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125544 Inflectra infliximab-dyyb 351(k) Biosimilar Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 INFLECTRA INFLIXIMAB-DYYB INJECTABLE;INJECTION 100MG Yes No
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join INFLECTRA INFLIXIMAB-DYYB Pfizer Laboratories Div Pfizer Inc 37eaca10-d812-48bc-8b8e-b836bfa9968f 2026-07-28 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125544 ndc (product): 0069-0809
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0069-0809 INFLECTRA infliximab-dyyb Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0809 INFLECTRA infliximab-dyyb Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0809 INFLECTRA infliximab-dyyb Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0809 INFLECTRA infliximab-dyyb Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0809 INFLECTRA infliximab-dyyb Pfizer Laboratories Div P BLA Current 0069-0809 INFLECTRA infliximab-dyyb Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0809 INFLECTRA infliximab-dyyb Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0809 INFLECTRA infliximab-dyyb Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0809 INFLECTRA infliximab-dyyb Pfizer Laboratories Div Pfizer Inc BLA Current