FDA.reportPublic FDA data

Application 125554

Type
BLA
Sponsor
BRISTOL MYERS SQUIBB

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125554Opdivonivolumab351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPDIVONIVOLUMABINJECTABLE;INJECTION40MG/4MLYesNo

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
OPDIVONIVOLUMABE.R. Squibb & Sons, L.L.C.f570b9c4-6846-4de2-abfa-4d0a4ae4e3942026-08-12Warnings, Adverse reactionsExact identifier
application number: BLA125554
ndc (product): 0003-3774

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 90 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-3774OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3774OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3774OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3774OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3774OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3774OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3774OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3774OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3774OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3774OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85932SUPPL 2026-05-18
85901SUPPL 2026-05-13
85517SUPPL 2026-03-24
85505SUPPL 2026-03-24
85447SUPPL 2026-03-23
82725SUPPL 2025-07-02
82723SUPPL 2025-07-02
82403SUPPL 2025-06-02
82335SUPPL 2025-05-28
81980SUPPL 2025-04-24
81941SUPPL 2025-04-21
81903SUPPL 2025-04-09
81880SUPPL 2025-04-08
79818SUPPL 2024-10-04
79816SUPPL 2024-10-03
77780SUPPL 2024-03-12
77760SUPPL 2024-03-11
77750SUPPL 2024-03-07
77747SUPPL 2024-03-07
76573SUPPL 2023-11-15
75756SUPPL 2023-10-16
75730SUPPL 2023-10-13
74716SUPPL 2023-07-11
74715SUPPL 2023-07-11
74652SUPPL 2023-06-29
73540SUPPL 2023-02-17
73539SUPPL 2023-02-17
73537SUPPL 2023-02-17
73528SUPPL 2023-02-16
73527SUPPL 2023-02-16
73526SUPPL 2023-02-16
71571SUPPL2022-07-15
71570SUPPL2022-07-15
71556SUPPL2022-07-15
71179SUPPL2022-05-31
71177SUPPL2022-05-31
71176SUPPL2022-05-31
71170SUPPL2022-05-31
71169SUPPL2022-05-31
71062SUPPL2022-05-12
71061SUPPL2022-05-12
71055SUPPL2022-05-12
70481SUPPL2022-03-10
70480SUPPL2022-03-10
70417SUPPL2022-03-07
70359SUPPL2022-03-02
70348SUPPL2022-03-02
70289SUPPL2022-02-28
68445SUPPL2021-08-24
68425SUPPL2021-08-20
68203SUPPL2021-07-27
68185SUPPL2021-07-26
68184SUPPL2021-07-26
68139SUPPL2021-07-20
68110SUPPL2021-07-19
67574SUPPL2021-05-24
67569SUPPL2021-05-20
67568SUPPL2021-05-20
67567SUPPL2021-05-20
67113SUPPL2021-04-19
67079SUPPL2021-04-16
67078SUPPL2021-04-16
66931SUPPL2021-03-31
66325SUPPL2021-02-23
66324SUPPL2021-02-23
65987SUPPL2021-01-26
65958SUPPL2021-01-22
65957SUPPL2021-01-22
65788SUPPL2020-12-31
65785SUPPL2020-12-31
65781SUPPL2020-12-30
65649SUPPL2020-12-21
65215SUPPL2020-11-13
65214SUPPL2020-11-13
65186SUPPL2020-11-12
64822SUPPL2020-10-05
64795SUPPL2020-10-02
64751SUPPL2020-09-29
64750SUPPL2020-09-29
64710SUPPL2020-09-28
64692SUPPL2020-09-25
64691SUPPL2020-09-25
64665SUPPL2020-09-24
64623SUPPL2020-09-21
64622SUPPL2020-09-21
63689SUPPL2020-06-24
63677SUPPL2020-06-24
63676SUPPL2020-06-24
63489SUPPL2020-06-12
63480SUPPL2020-06-11
63479SUPPL2020-06-11
63369SUPPL2020-06-01
63329SUPPL2020-05-29
63293SUPPL2020-05-26
63292SUPPL2020-05-26
63091SUPPL2020-05-19
63042SUPPL2020-05-15
62293SUPPL2020-03-24
62292SUPPL2020-03-24
62291SUPPL2020-03-24