Application 125288

Type
BLA
Sponsor
BRISTOL MYERS SQUIBB

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125288Nulojixbelatacept351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NULOJIXBELATACEPTINJECTABLE; INJECTION250MGNoNo

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
NULOJIXBELATACEPTE.R. Squibb & Sons, L.L.C.c16ac648-d5d2-9f7d-8637-e2328572754e2021-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125288
ndc (product): 0003-0371

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-0371NULOJIXBELATACEPTE.R. Squibb & Sons, L.L.C.BLACurrent
0003-0371NULOJIXBELATACEPTE.R. Squibb & Sons, L.L.C.BLACurrent
0003-0371NULOJIXBELATACEPTE.R. Squibb & Sons, L.L.C.BLACurrent
0003-0371NULOJIXBELATACEPTE.R. Squibb & Sons, L.L.C.BLACurrent
0003-0371NULOJIXBELATACEPTE.R. Squibb & Sons, L.L.C.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68224SUPPL2021-07-29
68220SUPPL2021-07-29
53697SUPPL2018-04-16
53672SUPPL2018-04-13
53671SUPPL2018-04-13
50390SUPPL2017-11-13
50373SUPPL2017-11-13
48363SUPPL2017-05-12
47103SUPPL2017-02-06
47081SUPPL2017-02-01
18845SUPPL2014-10-02
9675SUPPL2014-10-02
39896SUPPL2014-04-16
31894SUPPL2014-04-16
9674SUPPL2013-04-10
18844SUPPL2013-04-09
22797ORIG2011-08-08
9673ORIG2011-06-24
39895ORIG2011-06-16