Application 761133
- Type
- BLA
- Sponsor
- TAKEDA PHARMS USA
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENTYVIO | VEDOLIZUMAB | INJECTABLE;INTRAVENOUS | 300MG | No | No |
| 002 | ENTYVIO | VEDOLIZUMAB | INJECTABLE;INJECTION | 108MG/0.68ML | No | No |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85200 | SUPPL | 2026-03-02 |
| 85172 | SUPPL | 2026-02-27 |
| 79399 | ORIG | 2024-08-15 |
| 78405 | SUPPL | 2024-05-06 |
| 78404 | SUPPL | 2024-05-06 |
| 78175 | SUPPL | 2024-04-19 |
| 78174 | SUPPL | 2024-04-19 |
| 77846 | SUPPL | 2024-03-15 |
| 77841 | SUPPL | 2024-03-15 |
| 77840 | SUPPL | 2024-03-15 |
| 77628 | SUPPL | 2024-02-26 |
| 77619 | SUPPL | 2024-02-26 |
| 77618 | SUPPL | 2024-02-26 |
| 75599 | ORIG | 2023-09-28 |
| 75586 | ORIG | 2023-09-28 |