FDA.reportPublic FDA data

Application 125554

Type
BLA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3734OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3756OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3756OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3756OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3756OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3756OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3756OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-3772OPDIVOnivolumabE.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
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
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73528SUPPL 2023-02-16
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71571SUPPL2022-07-15
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71556SUPPL2022-07-15
71179SUPPL2022-05-31
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70481SUPPL2022-03-10
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70289SUPPL2022-02-28
68445SUPPL2021-08-24
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68203SUPPL2021-07-27
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66931SUPPL2021-03-31
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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
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63329SUPPL2020-05-29
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63091SUPPL2020-05-19
63042SUPPL2020-05-15
62293SUPPL2020-03-24
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