FDA.reportPublic FDA data

Application 125557

Type
BLA
Sponsor
AMGEN

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125557Blincytoblinatumomab351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BLINCYTOBLINATUMOMABINJECTABLE;INJECTION35MCGNoNo

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
BLINCYTOBLINATUMOMABAmgen, Inc38b482a8-960b-4591-9857-5031ecb830aa2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125557
ndc (product): 55513-160

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-160BLINCYTOblinatumomabAmgen IncBLACurrent
55513-160BLINCYTOblinatumomabAmgen IncBLACurrent
55513-160BLINCYTOblinatumomabAmgen IncBLACurrent
55513-160BLINCYTOblinatumomabAmgen IncBLACurrent
55513-160BLINCYTOblinatumomabAmgen IncBLACurrent
55513-160BLINCYTOblinatumomabAmgen IncBLACurrent
55513-160BLINCYTOblinatumomabAmgen IncBLACurrent
55513-160BLINCYTOblinatumomabAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83879SUPPL 2025-10-23
83867SUPPL 2025-10-22
82136SUPPL 2025-05-05
82074SUPPL 2025-04-30
82073SUPPL 2025-04-30
80615SUPPL 2024-12-18
80610SUPPL 2024-12-18
78812SUPPL 2024-06-18
78804SUPPL 2024-06-14
77444SUPPL 2024-02-09
77432SUPPL 2024-02-09
74571SUPPL 2023-06-21
74570SUPPL 2023-06-21
74561SUPPL 2023-06-21
74560SUPPL 2023-06-21
72796SUPPL2022-12-06
70211SUPPL2022-02-22
70196SUPPL2022-02-22
70195SUPPL2022-02-22
66759SUPPL2021-03-12
66754SUPPL2021-03-12
62294SUPPL2020-03-24
62265SUPPL2020-03-23
62221SUPPL2020-03-23
59049SUPPL2019-06-13
58378SUPPL2019-04-24
58377SUPPL2019-04-24
58354SUPPL2019-04-19
58353SUPPL2019-04-19
53757SUPPL2018-04-20
53582SUPPL2018-04-01
53544SUPPL2018-03-29
50570SUPPL2017-12-01
50549SUPPL2017-12-01
50548SUPPL2017-12-01
48987SUPPL2017-07-14
48952SUPPL2017-07-12
48820SUPPL2017-06-26
48289SUPPL2017-05-09
48244SUPPL2017-05-05
45208SUPPL2016-08-30
45207SUPPL2016-08-30
45185SUPPL2016-08-30
45184SUPPL2016-08-30
43339ORIG2015-01-12
24093ORIG2014-12-05
9787ORIG2014-12-04
39995ORIG2014-12-03
63253ORIG1900-01-01
63252ORIG1900-01-01
63251ORIG1900-01-01