Application 761343
- Type
- BLA
- Sponsor
- ALVOTECH USA INC
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SELARSDI | USTEKINUMAB-AEKN | INJECTABLE;INJECTION | 45MG/0.5ML | No | No |
| 002 | SELARSDI | USTEKINUMAB-AEKN | INJECTABLE;INJECTION | 90MG/ML | No | No |
Documents
| Document | Submission type | Date |
|---|---|---|
| 84351 | SUPPL | 2025-12-08 |
| 84347 | SUPPL | 2025-12-02 |
| 84249 | SUPPL | 2025-11-21 |
| 84248 | SUPPL | 2025-11-21 |
| 82152 | SUPPL | 2025-05-05 |
| 82268 | SUPPL | 2025-04-30 |
| 82267 | SUPPL | 2025-04-30 |
| 81636 | SUPPL | 2025-03-19 |
| 81635 | SUPPL | 2025-03-19 |
| 79955 | SUPPL | 2024-10-22 |
| 79951 | SUPPL | 2024-10-21 |
| 79950 | SUPPL | 2024-10-21 |
| 79949 | SUPPL | 2024-10-21 |
| 79947 | SUPPL | 2024-10-21 |
| 79932 | SUPPL | 2024-10-21 |
| 79931 | SUPPL | 2024-10-21 |
| 78885 | ORIG | 2024-06-25 |
| 78153 | ORIG | 2024-04-17 |
| 78152 | ORIG | 2024-04-16 |