Application 761364
- Type
- BLA
- Sponsor
- ACCORD BIOPHARMA INC.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IMULDOSA | USTEKINUMAB-SRLF | INJECTABLE;INTRAVENOUS | 45MG/0.5ML | No | No |
| 002 | IMULDOSA | USTEKINUMAB-SRLF | INJECTABLE;INTRAVENOUS | 90MG/ML | No | No |
| 003 | IMULDOSA | USTEKINUMAB-SRLF | INJECTABLE;INTRAVENOUS | 130MG/26ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84257 | SUPPL | 2025-11-21 |
| 84253 | SUPPL | 2025-11-21 |
| 84252 | SUPPL | 2025-11-21 |
| 82051 | ORIG | 2025-04-29 |
| 81630 | SUPPL | 2025-03-18 |
| 79874 | SUPPL | 2025-03-18 |
| 79876 | ORIG | 2024-10-15 |
| 79875 | ORIG | 2024-10-14 |