Home Applications 761064 Application 761064
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 761064 Rituxan Hycela rituximab and hyaluronidase human 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RITUXAN HYCELA RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) SOLUTION;SUBCUTANEOUS 1400MG and 23400UNITS/11.7ML No No 002 RITUXAN HYCELA RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) SOLUTION;SUBCUTANEOUS 1600MG and 26800UNITS/13.4ML 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.
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NDC Listings For This Application# NDC listings for this application page 1 of 1 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-108 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-108 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-108 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-108 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-108 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-108 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-108 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-108 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-108 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-108 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-109 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-109 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-109 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-109 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-109 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-109 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-109 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-109 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-109 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current 50242-109 Rituxan Hycela rituximab and hyaluronidase Genentech, Inc. BLA Current