Home Applications 103705 Application 103705
Type BLA
Sponsor GENENTECH Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103705 Rituxan rituximab 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RITUXAN RITUXIMAB SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) No No 002 RITUXAN RITUXIMAB SOLUTION;INTRAVENOUS 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 · 22 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-051 Rituxan rituximab Genentech, Inc. BLA Current 50242-051 Rituxan rituximab Genentech, Inc. BLA Current 50242-051 Rituxan rituximab Genentech, Inc. BLA Current 50242-051 Rituxan rituximab Genentech, Inc. BLA Current 50242-051 Rituxan rituximab Genentech, Inc. BLA Current 50242-051 Rituxan rituximab Genentech, Inc. BLA Current 50242-051 Rituxan rituximab Genentech, Inc. BLA Current 50242-051 Rituxan rituximab Genentech, Inc. BLA Current 50242-051 Rituxan rituximab Genentech, Inc. BLA Current 50242-051 Rituxan rituximab Genentech, Inc. BLA Current 50242-051 Rituxan rituximab Genentech, Inc. BLA Current 50242-053 Rituxan rituximab Genentech, Inc. BLA Current 50242-053 Rituxan rituximab Genentech, Inc. BLA Current 50242-053 Rituxan rituximab Genentech, Inc. BLA Current 50242-053 Rituxan rituximab Genentech, Inc. BLA Current 50242-053 Rituxan rituximab Genentech, Inc. BLA Current 50242-053 Rituxan rituximab Genentech, Inc. BLA Current 50242-053 Rituxan rituximab Genentech, Inc. BLA Current 50242-053 Rituxan rituximab Genentech, Inc. BLA Current 50242-053 Rituxan rituximab Genentech, Inc. BLA Current 50242-053 Rituxan rituximab Genentech, Inc. BLA Current 50242-053 Rituxan rituximab Genentech, Inc. BLA Current