FDA.reportPublic FDA data

Application 761234

Type
BLA
Sponsor
BRISTOL MYERS SQUIBB

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761234Opdualagnivolumab and relatlimab-rmbw351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPDUALAGNIVOLUMAB;ELATLIMAB-RMBWSOLUTION;INTRAVENOUS240MG;80MGNoNo

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
OPDUALAGNIVOLUMAB AND RELATLIMAB-RMBWE.R. Squibb & Sons, L.L.C.b22c9d83-3256-4e17-85f7-f331a504adc62026-06-08Warnings, Adverse reactionsExact identifier
application number: BLA761234
ndc (product): 0003-7125

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-7125OPDUALAGnivolumab and relatlimab-rmbwE.R. Squibb & Sons, L.L.C.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77788SUPPL 2024-03-12
77753SUPPL 2024-03-07
77752SUPPL 2024-03-07
70774ORIG2022-04-15
70575ORIG2022-03-21
70563ORIG2022-03-18
70562ORIG2022-03-18