Application 125399

Type
BLA
Sponsor
SEATTLE GENETICS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125399Adcetrisbrentuximab vedotin351(a)Rx2021-02-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADCETRISBRENTUXIMAB VEDOTININJECTABLE; INJECTION50MG/VIALNoNo

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADCETRISBRENTUXIMAB VEDOTINSEAGEN INC.3904f8dd-1aef-3490-e48f-bd55f32ed67f2025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ADCETRIS
generic name: BRENTUXIMAB VEDOTIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23952ORIG2012-02-13
43326ORIG2011-10-03
24369ORIG2011-10-03
18906ORIG2011-08-19
9739ORIG2011-08-19