Skip to contentApplication 218033
- Type
- NDA
- Sponsor
- DAY ONE BIOPHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OJEMDA | TOVORAFENIB | FOR SUSPENSION;ORAL | 25MG/ML | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83233 | SUPPL | 2025-08-29 |
| 83232 | SUPPL | 2025-08-29 |
| 83221 | SUPPL | 2025-08-28 |
| 83220 | SUPPL | 2025-08-28 |
| 78919 | SUPPL | 2024-06-27 |
| 78912 | SUPPL | 2024-06-27 |
| 78554 | ORIG | 2024-05-24 |
| 78538 | ORIG | 2024-05-22 |
| 78535 | ORIG | 2024-05-22 |