Application 761381
- Type
- BLA
- Sponsor
- BRISTOL-MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OPDIVO QVANTIG | NIVOLUMAB;HYALURONIDASE-NVHY | INJECTABLE;SUBCUTANEOUS | 600MG;10000UNITS PER5ML(120MG/2000UNITS PER ML) | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85950 | SUPPL | 2026-05-18 |
| 85949 | SUPPL | 2026-05-18 |
| 85909 | SUPPL | 2026-05-13 |
| 84313 | SUPPL | 2025-11-25 |
| 84312 | SUPPL | 2025-11-25 |
| 84307 | SUPPL | 2025-11-25 |
| 84144 | ORIG | 2025-11-13 |
| 84014 | SUPPL | 2025-10-31 |
| 83959 | SUPPL | 2025-10-28 |
| 83942 | SUPPL | 2025-10-28 |
| 83941 | SUPPL | 2025-10-28 |
| 80780 | ORIG | 2025-06-13 |
| 82399 | SUPPL | 2025-06-02 |
| 82337 | SUPPL | 2025-05-28 |
| 80807 | ORIG | 2025-01-03 |