Application 761349
- Type
- BLA
- Sponsor
- NOVARTIS PHARMS CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COSENTYX | SECUKINUMAB | INJECTABLE;INJECTION | 150MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85727 | SUPPL | 2026-04-21 |
| 85726 | SUPPL | 2026-04-21 |
| 85719 | SUPPL | 2026-04-20 |
| 85718 | SUPPL | 2026-04-20 |
| 85377 | SUPPL | 2026-03-16 |
| 83066 | SUPPL | 2025-08-21 |
| 83067 | SUPPL | 2025-08-08 |
| 81609 | SUPPL | 2025-03-17 |
| 81602 | SUPPL | 2025-03-17 |
| 79847 | SUPPL | 2024-10-09 |
| 79552 | ORIG | 2024-09-06 |
| 79446 | SUPPL | 2024-08-20 |
| 79436 | SUPPL | 2024-08-19 |
| 76661 | SUPPL | 2023-11-24 |
| 76668 | SUPPL | 2023-11-22 |
| 75691 | ORIG | 2023-10-10 |
| 75683 | ORIG | 2023-10-10 |