FDA.reportPublic FDA data

Application 125147

Type
BLA
Sponsor
AMGEN

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125147Vectibixpanitumumab351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VECTIBIXPANITUMUMABINJECTABLE; IV (INFUSION)5ML/100MGNoNo
002VECTIBIXPANITUMUMABINJECTABLE; IV (INFUSION)10ML/200MGNoNo
003VECTIBIXPANITUMUMABINJECTABLE; IV (INFUSION)20ML/400MGNoNo

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
VectibixPANITUMUMABAmgen, Ince0fa4bca-f245-4d92-ae29-b0c630a315c22026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125147
ndc (product): 55513-956
ndc (product): 55513-954

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-954VectibixpanitumumabAmgen IncBLACurrent
55513-954VectibixpanitumumabAmgen IncBLACurrent
55513-954VectibixpanitumumabAmgen IncBLACurrent
55513-954VectibixpanitumumabAmgen IncBLACurrent
55513-956VectibixpanitumumabAmgen IncBLACurrent
55513-956VectibixpanitumumabAmgen IncBLACurrent
55513-956VectibixpanitumumabAmgen IncBLACurrent
55513-956VectibixpanitumumabAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80867SUPPL 2025-01-17
80860SUPPL 2025-01-17
68498SUPPL2021-08-31
68475SUPPL2021-08-27
48899SUPPL2017-07-05
48873SUPPL2017-06-30
18803SUPPL2015-03-12
9624SUPPL2015-03-12
39860SUPPL2014-09-03
31847SUPPL2014-09-03
39859SUPPL2014-05-28
39857SUPPL2014-05-28
9623SUPPL2014-05-27
9620SUPPL2014-05-27
39858SUPPL2013-04-01
9622SUPPL2013-04-01
9621SUPPL2012-08-27
31846SUPPL2012-08-21
18802SUPPL2012-08-20
39856SUPPL2009-07-21
9619SUPPL2009-05-08
39855SUPPL2009-05-07
18801SUPPL2008-07-14
9618SUPPL2008-07-08
39854SUPPL2007-12-03
31845SUPPL2007-11-19
22789ORIG2006-11-30
31844ORIG2006-10-02
18800ORIG2006-09-28