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) Interchangeable Rx 2026-07-01
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# 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.
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