Application 761234
- Type
- BLA
- Sponsor
- BRISTOL MYERS SQUIBB
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761234 | Opdualag | nivolumab and relatlimab-rmbw | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OPDUALAG | NIVOLUMAB;ELATLIMAB-RMBW | SOLUTION;INTRAVENOUS | 240MG;80MG | No | No |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| OPDUALAG | NIVOLUMAB AND RELATLIMAB-RMBW | E.R. Squibb & Sons, L.L.C. | b22c9d83-3256-4e17-85f7-f331a504adc6 | 2026-06-08 | Warnings, Adverse reactions | BLA761234 0003-7125 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0003-7125 | OPDUALAG | nivolumab and relatlimab-rmbw | E.R. Squibb & Sons, L.L.C. | BLA | Current |