Home Applications 125019 Application 125019
Type BLA
Sponsor SPECTRUM PHARMS Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125019 Zevalin ibritumomab tiuxetan 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZEVALIN IBRITUMOMAB TIUXETAN INJECTABLE; INJECTION 3.2MG/2ML 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zevalin IBRITUMOMAB TIUXETAN Acrotech Biopharma Inc 25d367dc-da65-44c9-a844-1bf15339c285 2023-04-25 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125019 ndc (product): 72893-007
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68152-103 Zevalin ibritumomab tiuxetan Spectrum Pharmaceuticals, Inc. BLA Current 72893-007 Zevalin ibritumomab tiuxetan Acrotech Biopharma LLC BLA Current