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Application 216718
- Type
- NDA
- Sponsor
- BIOGEN US
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SKYCLARYS | OMAVELOXOLONE | CAPSULE;ORAL | 50MG | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85668 | SUPPL | 2026-04-10 |
| 85657 | SUPPL | 2026-04-09 |
| 80720 | SUPPL | 2024-12-26 |
| 80719 | SUPPL | 2024-12-26 |
| 80696 | SUPPL | 2024-12-23 |
| 80695 | SUPPL | 2024-12-23 |
| 77319 | SUPPL | 2024-01-26 |
| 77315 | SUPPL | 2024-01-26 |
| 77314 | SUPPL | 2024-01-26 |
| 73907 | ORIG | 2023-03-30 |
| 73643 | ORIG | 2023-03-01 |
| 73632 | ORIG | 2023-02-28 |