Application 217514
- Type
- NDA
- Sponsor
- NOVARTIS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAFINLAR | DABRAFENIB MESYLATE | TABLET, FOR SUSPENSION;ORAL | EQ 10MG BASE | Yes | Yes |
| 002 | TAFINLAR | DABRAFENIB MESYLATE | CAPSULE;ORAL | 75MG | No | No |
| 003 | TAFINLAR | DABRAFENIB MESYLATE | TABLET; ORAL SUSPENSION | 10MG | No | No |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85732 | SUPPL | 2026-04-21 |
| 85590 | SUPPL | 2026-03-30 |
| 81912 | SUPPL | 2025-04-09 |
| 81839 | SUPPL | 2025-04-08 |
| 81671 | SUPPL | 2025-03-21 |
| 81670 | SUPPL | 2025-03-21 |
| 81522 | SUPPL | 2025-03-11 |
| 81515 | SUPPL | 2025-03-11 |
| 81072 | SUPPL | 2025-02-06 |
| 80971 | SUPPL | 2025-02-05 |
| 79121 | SUPPL | 2024-07-18 |
| 79056 | SUPPL | 2024-07-12 |
| 78037 | SUPPL | 2024-04-03 |
| 78026 | SUPPL | 2024-04-01 |
| 77645 | SUPPL | 2024-02-28 |
| 77639 | SUPPL | 2024-02-28 |
| 74264 | ORIG | 2023-05-16 |
| 73798 | ORIG | 2023-03-17 |
| 73790 | ORIG | 2023-03-17 |