Home Applications 125276 Application 125276
Type BLA
Sponsor GENENTECH Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125276 Actemra tocilizumab 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ACTEMRA TOCILIZUMAB INJECTABLE; INJECTION 80MG/4ML No No 002 ACTEMRA TOCILIZUMAB INJECTABLE; INJECTION 200MG/10ML No No 003 ACTEMRA TOCILIZUMAB INJECTABLE; INJECTION 400MG/20ML 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 · 45 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-135 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-136 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current 50242-137 ACTEMRA tocilizumab Genentech, Inc. BLA Current