Application 125377

Type
BLA
Sponsor
BRISTOL MYERS SQUIBB

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125377Yervoyipilimumab351(a)Rx2026-07-01

Application Products#

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

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
YERVOYIPILIMUMABE.R. Squibb & Sons, L.L.C.2265ef30-253e-11df-8a39-0800200c9a662026-06-12Warnings, Adverse reactionsExact identifier
application number: BLA125377
ndc (product): 0003-2328
ndc (product): 0003-2327

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

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