FDA.reportPublic FDA data

Application 125031

Type
BLA
Sponsor
AMGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEULASTAPEGFILGRASTIMSYRINGE6MG/0.6MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-190NeulastapegfilgrastimAmgen IncBLACurrent
55513-190NeulastapegfilgrastimAmgen IncBLACurrent
55513-190NeulastapegfilgrastimAmgen IncBLACurrent
55513-190NeulastapegfilgrastimAmgen IncBLACurrent
55513-190NeulastapegfilgrastimAmgen IncBLACurrent
55513-190NeulastapegfilgrastimAmgen IncBLACurrent
55513-190NeulastapegfilgrastimAmgen IncBLACurrent
55513-190NeulastapegfilgrastimAmgen IncBLACurrent
55513-190NeulastapegfilgrastimAmgen IncBLACurrent
55513-190NeulastapegfilgrastimAmgen IncBLACurrent
55513-190NeulastapegfilgrastimAmgen IncBLACurrent
55513-192NeulastapegfilgrastimAmgen IncBLACurrent
55513-192NeulastapegfilgrastimAmgen IncBLACurrent
55513-192NeulastapegfilgrastimAmgen IncBLACurrent
55513-192NeulastapegfilgrastimAmgen IncBLACurrent
55513-192NeulastapegfilgrastimAmgen IncBLACurrent
55513-192NeulastapegfilgrastimAmgen IncBLACurrent
55513-192NeulastapegfilgrastimAmgen IncBLACurrent
55513-192NeulastapegfilgrastimAmgen IncBLACurrent
55513-192NeulastapegfilgrastimAmgen IncBLACurrent
55513-192NeulastapegfilgrastimAmgen IncBLACurrent
55513-192NeulastapegfilgrastimAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83286SUPPL 2025-09-05
83285SUPPL 2025-09-04
83283SUPPL 2025-09-04
67004SUPPL2021-04-07
66094SUPPL2021-02-04
66085SUPPL2021-02-03
65835SUPPL2021-01-06
65823SUPPL2021-01-06
65292SUPPL2020-11-19
65276SUPPL2020-11-19
61531SUPPL2020-01-07
61528SUPPL2020-01-07
58364SUPPL2019-04-22
58344SUPPL2019-04-18
54685SUPPL2018-06-26
54643SUPPL2018-06-21
50684SUPPL2017-12-13
50683SUPPL2017-12-13
50672SUPPL2017-12-13
50671SUPPL2017-12-13
50614SUPPL2017-12-06
48606SUPPL2017-05-31
9553SUPPL2016-05-03
39794SUPPL2016-04-29
31778SUPPL2015-12-23
39792SUPPL2015-11-19
62324SUPPL2015-11-13
39793SUPPL2015-10-06
39791SUPPL2015-10-06
18739SUPPL2015-10-06
31777SUPPL2015-09-24
9552SUPPL2015-09-24
9550SUPPL2015-09-24
9551SUPPL2014-12-30
39790SUPPL2012-05-29
31776SUPPL2012-05-29
31775SUPPL2011-06-15
9549SUPPL2010-03-31
31774SUPPL2008-12-04
9547SUPPL2008-12-04
9548SUPPL2008-05-22
18738SUPPL2007-08-02
9546SUPPL2007-08-01
39789SUPPL2006-11-09
31773SUPPL2006-11-09
18737SUPPL2006-02-08
39788SUPPL2005-01-26
39787SUPPL2005-01-26
9545SUPPL2005-01-26
9544SUPPL2005-01-26
22771ORIG2004-10-25
43577ORIG2004-03-25
18736ORIG2004-03-25
9543ORIG2004-03-25
53385ORIG1900-01-01
53384ORIG1900-01-01