Application 216834
- Type
- NDA
- Sponsor
- UCB INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZILBRYSQ | ZILUCOPLAN SODIUM | SOLUTION;SUBCUTANEOUS | EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) | Yes | Yes |
| 002 | ZILBRYSQ | ZILUCOPLAN SODIUM | SOLUTION;SUBCUTANEOUS | EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML) | Yes | Yes |
| 003 | ZILBRYSQ | ZILUCOPLAN SODIUM | SOLUTION;SUBCUTANEOUS | EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML) | Yes | Yes |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84843 | SUPPL | 2026-01-27 |
| 84842 | SUPPL | 2026-01-27 |
| 84827 | SUPPL | 2026-01-23 |
| 81426 | SUPPL | 2025-03-04 |
| 81425 | SUPPL | 2025-03-04 |
| 81395 | SUPPL | 2025-03-03 |
| 81394 | SUPPL | 2025-03-03 |
| 78298 | SUPPL | 2024-04-29 |
| 78291 | SUPPL | 2024-04-29 |
| 77232 | SUPPL | 2024-01-17 |
| 76558 | ORIG | 2023-11-13 |
| 75836 | ORIG | 2023-10-18 |
| 75825 | ORIG | 2023-10-17 |