Home Applications 125486 Application 125486
Type BLA
Sponsor GENENTECH Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125486 Gazyva obinutuzumab 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GAZYVA OBINUTUZUMAB INJECTABLE;INJECTION 1000MG/40ML 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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-070 Gazyva obinutuzumab Genentech, Inc. BLA Current 50242-070 Gazyva obinutuzumab Genentech, Inc. BLA Current 50242-070 Gazyva obinutuzumab Genentech, Inc. BLA Current 50242-070 Gazyva obinutuzumab Genentech, Inc. BLA Current 50242-070 Gazyva obinutuzumab Genentech, Inc. BLA Current 50242-070 Gazyva obinutuzumab Genentech, Inc. BLA Current 50242-070 Gazyva obinutuzumab Genentech, Inc. BLA Current