Home Applications 761053 Application 761053
Type BLA
Sponsor GENENTECH INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761053 Ocrevus ocrelizumab 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OCREVUS OCRELIZUMAB INJECTABLE;INJECTION 30MG/1ML 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 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-150 OCREVUS ocrelizumab Genentech, Inc. BLA Current 50242-150 OCREVUS ocrelizumab Genentech, Inc. BLA Current 50242-150 OCREVUS ocrelizumab Genentech, Inc. BLA Current 50242-150 OCREVUS ocrelizumab Genentech, Inc. BLA Current 50242-150 OCREVUS ocrelizumab Genentech, Inc. BLA Current 50242-150 OCREVUS ocrelizumab Genentech, Inc. BLA Current 50242-150 OCREVUS ocrelizumab Genentech, Inc. BLA Current 50242-150 OCREVUS ocrelizumab Genentech, Inc. BLA Current 50242-150 OCREVUS ocrelizumab Genentech, Inc. BLA Current 50242-150 OCREVUS ocrelizumab Genentech, Inc. BLA Current 50242-150 OCREVUS ocrelizumab Genentech, Inc. BLA Current