Skip to contentApplication 218160
- Type
- NDA
- Sponsor
- ELI LILLY AND CO
Application Products#
Product, Drug, Ingredient table| 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, Submission type, Date table| Document | Submission type | Date |
|---|
| 84267 | SUPPL | 2025-11-21 |
| 84266 | SUPPL | 2025-11-21 |
| 84262 | SUPPL | 2025-11-21 |
| 84261 | SUPPL | 2025-11-21 |
| 81773 | ORIG | 2025-03-28 |
| 80646 | SUPPL | 2024-12-19 |
| 80639 | SUPPL | 2024-12-19 |
| 79767 | SUPPL | 2024-09-30 |
| 79766 | SUPPL | 2024-09-30 |
| 79760 | SUPPL | 2024-09-30 |
| 79759 | SUPPL | 2024-09-30 |
| 78786 | SUPPL | 2024-06-13 |
| 78778 | SUPPL | 2024-06-12 |
| 78113 | ORIG | 2024-04-12 |
| 78105 | ORIG | 2024-04-10 |