FDA.reportPublic FDA data

Application 125031

Type
BLA
Sponsor
AMGEN

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125031Neulastapegfilgrastim351(a)Rx2026-09-01

Application Products#

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

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
NeulastaPEGFILGRASTIMAmgen, Incfdfe5d72-6b80-435a-afa4-c5d74dd852ce2026-08-10Warnings, Adverse reactionsExact identifier
application number: BLA125031
ndc (product): 55513-192
ndc (product): 55513-190

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 · 22 matching rows.

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