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Application 216099
- Type
- NDA
- Sponsor
- HANDA THERAP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PHYRAGO | DASATINIB | TABLET;ORAL | 20MG | Yes | No |
| 002 | PHYRAGO | DASATINIB | TABLET;ORAL | 50MG | Yes | No |
| 003 | PHYRAGO | DASATINIB | TABLET;ORAL | 70MG | Yes | No |
| 004 | PHYRAGO | DASATINIB | TABLET;ORAL | 80MG | Yes | No |
| 005 | PHYRAGO | DASATINIB | TABLET;ORAL | 100MG | Yes | Yes |
| 006 | PHYRAGO | DASATINIB | TABLET;ORAL | 140MG | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83050 | SUPPL | 2025-08-05 |
| 83038 | SUPPL | 2025-08-04 |
| 80524 | SUPPL | 2024-12-05 |
| 80502 | SUPPL | 2024-12-04 |
| 79744 | ORIG | 2024-09-26 |
| 79283 | SUPPL | 2024-08-02 |
| 79275 | SUPPL | 2024-08-02 |
| 76742 | ORIG | 2023-12-06 |
| 74316 | ORIG | 2023-12-06 |