Application 217513
- Type
- NDA
- Sponsor
- NOVARTIS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE | SOLUTION;ORAL | EQ 0.05MG BASE/ML | Yes | Yes |
| 002 | MEKINIST | TRAMETINIB | TABLET;ORAL | 2MG | No | No |
| 003 | MEKINIST | TRAMETINIB | SOLUTION;ORAL | 4.7MG | No | No |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85625 | SUPPL | 2026-04-02 |
| 85592 | SUPPL | 2026-03-30 |
| 81911 | SUPPL | 2025-04-09 |
| 81837 | SUPPL | 2025-04-08 |
| 81667 | SUPPL | 2025-03-21 |
| 81525 | SUPPL | 2025-03-21 |
| 81658 | SUPPL | 2025-03-20 |
| 81657 | SUPPL | 2025-03-20 |
| 81513 | SUPPL | 2025-03-11 |
| 81257 | SUPPL | 2025-02-14 |
| 79970 | SUPPL | 2024-10-24 |
| 79811 | SUPPL | 2024-10-03 |
| 79100 | SUPPL | 2024-07-15 |
| 79058 | SUPPL | 2024-07-12 |
| 78036 | SUPPL | 2024-04-03 |
| 78025 | SUPPL | 2024-04-01 |
| 77647 | SUPPL | 2024-02-28 |
| 77637 | SUPPL | 2024-02-28 |
| 74265 | ORIG | 2023-05-16 |
| 73797 | ORIG | 2023-03-17 |
| 73795 | ORIG | 2023-03-17 |