FDA.report

Application 125147

Type
BLA
Sponsor
AMGEN

Related Records

Application Products

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

NDC Listings For This Application

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

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