Home Applications 761103 Application 761103
Type BLA
Sponsor PFIZER INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761103 Ruxience rituximab-pvvr 351(k) Biosimilar Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RUXIENCE RITUXIMAB-PVVR INJECTABLE;INJECTION 100MG/10ML(10MG/ML) No No 002 RUXIENCE RITUXIMAB-PVVR INJECTABLE;INJECTION 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0069-0238 Ruxience rituximab-pvvr Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0238 Ruxience rituximab-pvvr Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0238 Ruxience rituximab-pvvr Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0249 Ruxience rituximab-pvvr Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0249 Ruxience rituximab-pvvr Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0249 Ruxience rituximab-pvvr Pfizer Laboratories Div Pfizer Inc BLA Current