FDA.reportPublic FDA data

Application 125377

Type
BLA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001YERVOYIPILIMUMABINJECTABLE; INJECTION3MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2327YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2328YERVOYipilimumabE.R. Squibb & Sons, L.L.C.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82402SUPPL 2025-06-02
82401SUPPL 2025-06-02
82334SUPPL 2025-05-28
82010SUPPL 2025-04-25
81940SUPPL 2025-04-21
81902SUPPL 2025-04-09
81881SUPPL 2025-04-08
81173SUPPL 2025-02-07
80996SUPPL 2025-02-05
73533SUPPL 2023-02-17
73529SUPPL 2023-02-16
72723SUPPL2022-11-28
72722SUPPL2022-11-27
72700SUPPL2022-11-25
71181SUPPL2022-05-31
71180SUPPL2022-05-31
71168SUPPL2022-05-31
71064SUPPL2022-05-12
71063SUPPL2022-05-12
71054SUPPL2022-05-12
70385SUPPL2022-03-03
70288SUPPL2022-02-28
70287SUPPL2022-02-28
70282SUPPL2022-02-28
70281SUPPL2022-02-28
69648SUPPL2021-12-20
67589SUPPL2021-05-25
67581SUPPL2021-05-24
67580SUPPL2021-05-24
65648SUPPL2020-12-21
65230SUPPL2020-11-16
65228SUPPL2020-11-16
65222SUPPL2020-11-16
64821SUPPL2020-10-05
64794SUPPL2020-10-02
64648SUPPL2020-09-22
64647SUPPL2020-09-22
64624SUPPL2020-09-21
64282SUPPL2020-08-14
64281SUPPL2020-08-14
64280SUPPL2020-08-14
63769SUPPL2020-07-01
63749SUPPL2020-06-30
63748SUPPL2020-06-30
63328SUPPL2020-05-29
63295SUPPL2020-05-26
63294SUPPL2020-05-26
63089SUPPL2020-05-19
63050SUPPL2020-05-15
62125SUPPL2020-03-11
62118SUPPL2020-03-11
62111SUPPL2020-03-11
60088SUPPL2019-09-23
60085SUPPL2019-09-23
58691SUPPL2019-05-14
58653SUPPL2019-05-13
54901SUPPL2018-07-16
54869SUPPL2018-07-11
53713SUPPL2018-04-17
53678SUPPL2018-04-16
52545SUPPL2018-02-09
52525SUPPL2018-02-09
50751SUPPL2017-12-18
50695SUPPL2017-12-14
50163SUPPL2017-10-24
50138SUPPL2017-10-23
49075SUPPL2017-07-25
49051SUPPL2017-07-25
51940SUPPL2017-07-20
51939SUPPL2017-07-20
47502SUPPL2017-03-08
18894SUPPL2016-04-19
9728SUPPL2015-10-30
9729SUPPL2015-08-19
39942SUPPL2015-08-18
18893SUPPL2015-03-24
9727SUPPL2015-03-20
9726SUPPL2013-12-09
39941SUPPL2013-12-06
31946SUPPL2013-05-28
39940SUPPL2013-05-23
31945SUPPL2012-10-30
18892SUPPL2012-10-30
9725SUPPL2012-02-23
24365ORIG2011-06-08
22805ORIG2011-05-16
9724ORIG2011-03-29
18891ORIG2011-03-25
51209SUPPL1900-01-01
51208SUPPL1900-01-01