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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

Documents#

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