FDA.reportPublic FDA data

Application 103353

Type
BLA
Sponsor
AMGEN

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103353Neupogenfilgrastim351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEUPOGENFILGRASTIMVIAL300MCG/1MLNoNo
002NEUPOGENFILGRASTIMVIAL480MCG/1.6MLNoNo
003NEUPOGENFILGRASTIMSYRINGE300MGC/0.5MLNoNo
004NEUPOGENFILGRASTIMSYRINGE480MCG/0.8MLNoNo

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
NEUPOGENFILGRASTIMAmgen, Inc97cc73cc-b5b7-458a-a933-77b00523e1932026-07-23Warnings, Adverse reactionsExact identifier
application number: BLA103353
ndc (product): 55513-546
ndc (product): 55513-924
ndc (product): 55513-209
ndc (product): 55513-530

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-209NEUPOGENFilgrastimAmgen IncBLACurrent
55513-209NEUPOGENFilgrastimAmgen IncBLACurrent
55513-209NEUPOGENFilgrastimAmgen IncBLACurrent
55513-209NEUPOGENFilgrastimAmgen IncBLACurrent
55513-209NEUPOGENFilgrastimAmgen IncBLACurrent
55513-209NEUPOGENFilgrastimAmgen IncBLACurrent
55513-209NEUPOGENFilgrastimAmgen IncBLACurrent
55513-530NEUPOGENFilgrastimAmgen IncBLACurrent
55513-530NEUPOGENFilgrastimAmgen IncBLACurrent
55513-530NEUPOGENFilgrastimAmgen IncBLACurrent
55513-530NEUPOGENFilgrastimAmgen IncBLACurrent
55513-530NEUPOGENFilgrastimAmgen IncBLACurrent
55513-530NEUPOGENFilgrastimAmgen IncBLACurrent
55513-530NEUPOGENFilgrastimAmgen IncBLACurrent
55513-546NEUPOGENFilgrastimAmgen IncBLACurrent
55513-546NEUPOGENFilgrastimAmgen IncBLACurrent
55513-546NEUPOGENFilgrastimAmgen IncBLACurrent
55513-546NEUPOGENFilgrastimAmgen IncBLACurrent
55513-546NEUPOGENFilgrastimAmgen IncBLACurrent
55513-546NEUPOGENFilgrastimAmgen IncBLACurrent
55513-546NEUPOGENFilgrastimAmgen IncBLACurrent
55513-924NEUPOGENFilgrastimAmgen IncBLACurrent
55513-924NEUPOGENFilgrastimAmgen IncBLACurrent
55513-924NEUPOGENFilgrastimAmgen IncBLACurrent
55513-924NEUPOGENFilgrastimAmgen IncBLACurrent
55513-924NEUPOGENFilgrastimAmgen IncBLACurrent
55513-924NEUPOGENFilgrastimAmgen IncBLACurrent
55513-924NEUPOGENFilgrastimAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82027SUPPL 2025-04-28
82001SUPPL 2025-04-25
74023SUPPL 2023-04-19
74020SUPPL 2023-04-19
66121SUPPL2021-02-08
66114SUPPL2021-02-05
65836SUPPL2021-01-06
65824SUPPL2021-01-06
54686SUPPL2018-06-26
54642SUPPL2018-06-21
48095SUPPL2017-04-25
39649SUPPL2016-07-22
31584SUPPL2016-06-30
18577SUPPL2015-08-04
31583SUPPL2015-07-31
31582SUPPL2015-04-03
18576SUPPL2015-02-06
9386SUPPL2015-02-06
18575SUPPL2013-09-17
9385SUPPL2013-09-17
39648SUPPL2012-05-29
9384SUPPL2012-05-29
22734ORIG2011-12-02
18574SUPPL2010-03-11
31581SUPPL2010-03-08
31580SUPPL2006-11-09
18573SUPPL2006-11-09
31579SUPPL2005-01-26
18572SUPPL2005-01-26
39647SUPPL2004-03-25
39646SUPPL2004-03-25
9383SUPPL2004-03-25
9382SUPPL2004-03-25