Application 220258
- Type
- NDA
- Sponsor
- AZURITY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RESNIBEN | CABOZANTINIB | TABLET; ORAL | 13MG | No | No |
| 002 | RESNIBEN | CABOZANTINIB | TABLET; ORAL | 26MG | No | No |
| 003 | RESNIBEN | CABOZANTINIB | TABLET; ORAL | 39MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83950 | ORIG | 2025-10-28 |