Application 761234
- Type
- BLA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OPDUALAG | NIVOLUMAB;ELATLIMAB-RMBW | SOLUTION;INTRAVENOUS | 240MG;80MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0003-7125 | OPDUALAG | nivolumab and relatlimab-rmbw | E.R. Squibb & Sons, L.L.C. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77788 | SUPPL | 2024-03-12 |
| 77753 | SUPPL | 2024-03-07 |
| 77752 | SUPPL | 2024-03-07 |
| 70774 | ORIG | 2022-04-15 |
| 70575 | ORIG | 2022-03-21 |
| 70563 | ORIG | 2022-03-18 |
| 70562 | ORIG | 2022-03-18 |