FDA.reportPublic FDA data

Application 125118

Type
BLA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

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

NDC Listings For This Application#

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.CBLACurrent
0003-2187ORENCIAabataceptE.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.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.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
0003-2818ORENCIAabataceptE.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