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Application 761354
- Type
- BLA
- Sponsor
- BIOGEN MA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TOFIDENCE | TOCILIZUMAB-BAVI | INJECTABLE;INJECTION | 80MG/4ML | No | No |
| 002 | TOFIDENCE | TOCILIZUMAB-BAVI | INJECTABLE;INJECTION | 200MG/10ML | No | No |
| 003 | TOFIDENCE | TOCILIZUMAB-BAVI | INJECTABLE;INJECTION | 400MG/20ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81517 | SUPPL | 2025-03-11 |
| 81516 | SUPPL | 2025-03-11 |
| 81475 | SUPPL | 2025-03-07 |
| 80527 | SUPPL | 2024-12-05 |
| 80505 | SUPPL | 2024-12-04 |
| 79161 | SUPPL | 2024-07-24 |
| 79153 | SUPPL | 2024-07-23 |
| 76519 | ORIG | 2023-11-07 |
| 75655 | ORIG | 2023-10-03 |
| 75629 | ORIG | 2023-09-29 |