Skip to contentApplication 215559
- Type
- NDA
- Sponsor
- IPSEN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SOHONOS | PALOVAROTENE | CAPSULE;ORAL | 1MG | Yes | No |
| 002 | SOHONOS | PALOVAROTENE | CAPSULE;ORAL | 1.5MG | Yes | No |
| 003 | SOHONOS | PALOVAROTENE | CAPSULE;ORAL | 2.5MG | Yes | No |
| 004 | SOHONOS | PALOVAROTENE | CAPSULE;ORAL | 5MG | Yes | No |
| 005 | SOHONOS | PALOVAROTENE | CAPSULE;ORAL | 10MG | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81607 | SUPPL | 2025-03-17 |
| 81596 | SUPPL | 2025-03-17 |
| 81595 | SUPPL | 2025-03-17 |
| 75489 | ORIG | 2023-09-15 |
| 75111 | ORIG | 2023-08-17 |
| 75108 | ORIG | 2023-08-17 |