Application 225554
- Type
- BLA
- Sponsor
- BRISTOL-MYERS SQUIBB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OPDIVO | NIVOLUMAB | INJECTABLE;INJECTION, SOLUTION | 40MG/4ML | No | No |
| 002 | OPDIVO | NIVOLUMAB | INJECTABLE;INJECTION, SOLUTION | 100MG/10ML | No | No |
| 003 | OPDIVO | NIVOLUMAB | INJECTABLE;INJECTION, SOLUTION | 120MG/12ML | No | No |
| 004 | OPDIVO | NIVOLUMAB | INJECTABLE;INJECTION, SOLUTION | 240MG/124ML | 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 |
|---|---|---|---|---|---|---|
| OPDIVO | NIVOLUMAB | E.R. Squibb & Sons, L.L.C. | f570b9c4-6846-4de2-abfa-4d0a4ae4e394 | 2026-05-12 | Warnings, Adverse reactions | OPDIVO NIVOLUMAB |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 70403 | ORIG | 2022-03-07 |