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 2026-07-01
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# 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 · 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