FDA.reportPublic FDA data

Application 125019

Type
BLA
Sponsor
SPECTRUM PHARMS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125019Zevalinibritumomab tiuxetan351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEVALINIBRITUMOMAB TIUXETANINJECTABLE; INJECTION3.2MG/2MLNoNo

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZevalinIBRITUMOMAB TIUXETANAcrotech Biopharma Inc25d367dc-da65-44c9-a844-1bf15339c2852023-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125019
ndc (product): 72893-007

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68152-103Zevalinibritumomab tiuxetanSpectrum Pharmaceuticals, Inc.BLACurrent
72893-007Zevalinibritumomab tiuxetanAcrotech Biopharma LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56843SUPPL2018-12-20
56714SUPPL2018-12-12
39784SUPPL2013-09-09
39783SUPPL2013-09-09
31769SUPPL2013-09-05
9541SUPPL2013-09-05
31768SUPPL2011-12-02
18733SUPPL2011-11-30
39782SUPPL2009-09-18
9540SUPPL2009-09-10
9539SUPPL2008-03-28
18732SUPPL2008-03-27
39781SUPPL2007-11-13
31767SUPPL2007-11-08
22770ORIG2005-12-08
39780SUPPL2005-09-15
31766SUPPL2005-09-15
39779SUPPL2005-08-08
31765SUPPL2005-08-08
39778SUPPL2005-01-26
39777SUPPL2005-01-26
31764SUPPL2005-01-26
9538SUPPL2005-01-26
31763ORIG2004-03-30
18731ORIG2004-03-30