Application 125118

Type
BLA
Sponsor
BRISTOL MYERS SQUIBB

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125118Orenciaabatacept351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORENCIAABATACEPTINJECTABLE; IV (INFUSION)250MGNoNo

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
ORENCIAABATACEPTE.R. Squibb & Sons, L.L.C.0836c6ac-ee37-5640-2fed-a3185a0b16eb2025-11-13Warnings, Adverse reactionsExact identifier
application number: BLA125118
ndc (product): 0003-2188
ndc (product): 0003-2818
ndc (product): 0003-2187
ndc (product): 0003-2814

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-2187ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2187ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2187ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2187ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2187ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2187ORENCIAabataceptE.R. Squibb & Sons, L.L.CBLACurrent
0003-2188ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2188ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2188ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2188ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2188ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2188ORENCIAabataceptE.R. Squibb & Sons, L.L.CBLACurrent
0003-2814ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2814ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2814ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2814ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2814ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2814ORENCIAabataceptE.R. Squibb & Sons, L.L.CBLACurrent
0003-2818ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2818ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2818ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2818ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2818ORENCIAabataceptE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2818ORENCIAabataceptE.R. Squibb & Sons, L.L.CBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78603SUPPL 2024-05-31
78579SUPPL 2024-05-30
77274SUPPL 2024-01-23
77268SUPPL 2024-01-23
76006SUPPL 2023-10-31
75988SUPPL 2023-10-31
75510SUPPL 2023-09-18
70767SUPPL2022-04-15
69682SUPPL2021-12-20
69553SUPPL2021-12-15
63649SUPPL2020-06-22
63648SUPPL2020-06-22
63647SUPPL2020-06-22
63631SUPPL2020-06-19
63630SUPPL2020-06-19
63629SUPPL2020-06-19
58067SUPPL2019-03-22
48902SUPPL2017-07-05
48889SUPPL2017-07-03
47822SUPPL2017-04-03
47808SUPPL2017-03-31
45792SUPPL2016-11-02
9616SUPPL2015-01-07
18796SUPPL2015-01-05
22787SUPPL2014-01-17
9615SUPPL2013-12-24
39852SUPPL2013-12-23
31840SUPPL2012-02-23
39851SUPPL2012-02-22
31839SUPPL2011-08-11
31838SUPPL2009-09-01
39850SUPPL2009-08-27
9614SUPPL2008-06-03
18795SUPPL2007-03-13
22786ORIG2006-05-16
31837ORIG2006-01-06
39849ORIG2005-12-30
63846ORIG1900-01-01
63845SUPPL1900-01-01
54027ORIG1900-01-01
54026ORIG1900-01-01
51937SUPPL1900-01-01
51234SUPPL1900-01-01
51232SUPPL1900-01-01