Home Applications 761088 Application 761088
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 761088 Truxima rituximab-abbs 351(k) Biosimilar Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRUXIMA RITUXIMAB-ABBS INJECTABLE;INJECTION 100MG/10ML(10MG/ML) No No 002 TRUXIMA RITUXIMAB-ABBS INJECTABLE;INJECTION 500MG/50ML(10MG/ML) No 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63459-103 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-103 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-103 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-103 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-103 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-103 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-103 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-103 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-104 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-104 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-104 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-104 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-104 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-104 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-104 Truxima rituximab-abbs Cephalon, Inc. BLA Current 63459-104 Truxima rituximab-abbs Cephalon, Inc. BLA Current