Application 125388

Type
BLA
Sponsor
SEATTLE GENETICS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125388Adcetrisbrentuximab vedotin351(a)Rx2026-06-01

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 · 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 reactionsExact identifier
application number: BLA125388
ndc (product): 51144-050

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51144-050ADCETRISbrentuximab vedotinSEAGEN INC.BLACurrent
51144-050ADCETRISbrentuximab vedotinSeattle Genetics, Inc.BLACurrent
51144-050ADCETRISbrentuximab vedotinSeattle Genetics, Inc.BLACurrent
51144-050ADCETRISbrentuximab vedotinSEAGEN INC.BLACurrent
51144-050ADCETRISbrentuximab vedotinSEAGEN INC.BLACurrent
51144-050ADCETRISbrentuximab vedotinSEAGEN INC.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81222SUPPL 2025-02-12
81217SUPPL 2025-02-12
74644SUPPL 2023-06-28
74498SUPPL 2023-06-15
74490SUPPL 2023-06-15
72609SUPPL2022-11-14
72599SUPPL2022-11-13
60581SUPPL2019-10-24
60573SUPPL2019-10-16
56524SUPPL2018-11-20
56505SUPPL2018-11-19
53494SUPPL2018-03-28
53068SUPPL2018-03-20
50367SUPPL2017-11-13
50348SUPPL2017-11-09
47285SUPPL2017-02-22
45497SUPPL2016-09-30
39951SUPPL2016-03-08
31955SUPPL2016-03-08
39950SUPPL2015-08-17
31954SUPPL2015-08-17
18902SUPPL2015-08-17
9738SUPPL2015-08-17
31953SUPPL2014-11-26
9737SUPPL2014-11-26
18901SUPPL2014-11-25
18900SUPPL2014-11-25
9736SUPPL2013-08-22
39949SUPPL2013-08-21
44429ORIG2012-02-13
31952SUPPL2012-01-19
18899SUPPL2012-01-13
43325ORIG2011-10-03
24367ORIG2011-10-03
39948ORIG2011-08-19
31951ORIG2011-08-19