FDA.reportPublic FDA data

Application 125268

Type
BLA
Sponsor
AMGEN

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125268Nplateromiplostim351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NPLATEROMIPLOSTIMINJECTABLE; SUBCUTANEOUS250MCG/0.5ML; 500MCG/1ML.YesNo

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
NplateROMIPLOSTIMAmgen, Incc45f9a58-37c1-4f76-8e36-97d38c5770372026-06-23Warnings, Adverse reactionsExact identifier
application number: BLA125268
ndc (product): 55513-221
ndc (product): 55513-222
ndc (product): 55513-223

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-221NplateromiplostimAmgen IncBLACurrent
55513-221NplateromiplostimAmgen IncBLACurrent
55513-221NplateromiplostimAmgen IncBLACurrent
55513-221NplateromiplostimAmgen IncBLACurrent
55513-221NplateromiplostimAmgen IncBLACurrent
55513-221NplateromiplostimAmgen IncBLACurrent
55513-221NplateromiplostimAmgen IncBLACurrent
55513-221NplateromiplostimAmgen IncBLACurrent
55513-221NplateromiplostimAmgen IncBLACurrent
55513-221NplateromiplostimAmgen IncBLACurrent
55513-222NplateromiplostimAmgen IncBLACurrent
55513-222NplateromiplostimAmgen IncBLACurrent
55513-222NplateromiplostimAmgen IncBLACurrent
55513-222NplateromiplostimAmgen IncBLACurrent
55513-222NplateromiplostimAmgen IncBLACurrent
55513-222NplateromiplostimAmgen IncBLACurrent
55513-222NplateromiplostimAmgen IncBLACurrent
55513-222NplateromiplostimAmgen IncBLACurrent
55513-222NplateromiplostimAmgen IncBLACurrent
55513-222NplateromiplostimAmgen IncBLACurrent
55513-223NplateromiplostimAmgen IncBLACurrent
55513-223NplateromiplostimAmgen IncBLACurrent
55513-223NplateromiplostimAmgen IncBLACurrent
55513-223NplateromiplostimAmgen IncBLACurrent
55513-223NplateromiplostimAmgen IncBLACurrent
55513-223NplateromiplostimAmgen IncBLACurrent
55513-223NplateromiplostimAmgen IncBLACurrent
55513-223NplateromiplostimAmgen IncBLACurrent
55513-223NplateromiplostimAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81771SUPPL 2025-03-28
81357SUPPL 2025-02-25
81341SUPPL 2025-02-24
81340SUPPL 2025-02-21
70149SUPPL2022-02-14
70146SUPPL2022-02-11
66234SUPPL2021-02-16
66195SUPPL2021-02-11
66046SUPPL2021-02-01
66027SUPPL2021-02-01
66017SUPPL2021-01-29
66016SUPPL2021-01-29
65327SUPPL2020-11-25
65322SUPPL2020-11-25
60588SUPPL2019-10-18
60583SUPPL2019-10-18
60582SUPPL2019-10-18
56913SUPPL2018-12-21
56745SUPPL2018-12-14
48658SUPPL2017-06-06
48657SUPPL2017-06-06
39888SUPPL2016-04-20
31880SUPPL2016-04-20
18831SUPPL2016-04-20
9660SUPPL2016-04-20
31879SUPPL2014-02-12
18830SUPPL2014-02-11
39887SUPPL2013-06-04
9659SUPPL2013-05-31
31878SUPPL2012-11-07
39886SUPPL2012-11-06
31877SUPPL2011-12-14
18829SUPPL2011-12-06
9658SUPPL2010-06-10
9657SUPPL2010-06-10
18828SUPPL2009-09-18
31876SUPPL2009-09-09
44563ORIG2008-10-22
44794ORIG2008-10-17
22793ORIG2008-10-17
31875ORIG2008-08-25
18827ORIG2008-08-25