Skip to contentApplication 216593
- Type
- NDA
- Sponsor
- NOVA LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XROMI | HYDROXYUREA | SOLUTION;ORAL | 100MG/ML | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83645 | ORIG | 2025-10-03 |
| 80755 | ORIG | 2024-12-27 |
| 80754 | ORIG | 2024-12-27 |
| 78076 | ORIG | 2024-12-27 |
| 80418 | ORIG | 2024-11-25 |
| 80417 | ORIG | 2024-11-25 |
| 79954 | SUPPL | 2024-10-21 |
| 79953 | SUPPL | 2024-10-21 |
| 79923 | SUPPL | 2024-10-21 |
| 78088 | ORIG | 2024-04-08 |
| 78075 | ORIG | 2024-04-05 |