Application 218160
- Type
- NDA
- Sponsor
- ELI LILLY AND CO
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RETEVMO | SELPERCATINIB | TABLET;ORAL | 40MG | Yes | No |
| 002 | RETEVMO | SELPERCATINIB | TABLET;ORAL | 80MG | Yes | No |
| 003 | RETEVMO | SELPERCATINIB | TABLET;ORAL | 120MG | Yes | No |
| 004 | RETEVMO | SELPERCATINIB | TABLET;ORAL | 160MG | Yes | Yes |
| 005 | RETEVMO | SELPERCATINIB | CAPSULE;ORAL | 40MG | No | No |
| 006 | RETEVMO | SELPERCATINIB | CAPSULE;ORAL | 80MG | No | No |
Documents
| Document | Title | Submission type | Submission no. | Date |
|---|
| 84267 | 0 | SUPPL | 6 | 2025-11-21 |
| 84266 | 0 | SUPPL | 5 | 2025-11-21 |
| 84262 | 0 | SUPPL | 6 | 2025-11-21 |
| 84261 | 0 | SUPPL | 5 | 2025-11-21 |
| 81773 | 0 | ORIG | 1 | 2025-03-28 |
| 80646 | 0 | SUPPL | 4 | 2024-12-19 |
| 80639 | 0 | SUPPL | 4 | 2024-12-19 |
| 79767 | 0 | SUPPL | 3 | 2024-09-30 |
| 79766 | 0 | SUPPL | 2 | 2024-09-30 |
| 79760 | 0 | SUPPL | 3 | 2024-09-30 |
| 79759 | 0 | SUPPL | 2 | 2024-09-30 |
| 78786 | 0 | SUPPL | 1 | 2024-06-13 |
| 78778 | 0 | SUPPL | 1 | 2024-06-12 |
| 78113 | 0 | ORIG | 1 | 2024-04-12 |
| 78105 | 0 | ORIG | 1 | 2024-04-10 |