Skip to contentApplication 219304
- Type
- NDA
- Sponsor
- DECIPHERA PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ROMVIMZA | VIMSELTINIB | CAPSULE;ORAL | 14MG | Yes | No |
| 002 | ROMVIMZA | VIMSELTINIB | CAPSULE;ORAL | 20MG | Yes | No |
| 003 | ROMVIMZA | VIMSELTINIB | CAPSULE;ORAL | 30MG | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85996 | SUPPL | 2026-05-21 |
| 84415 | SUPPL | 2025-12-15 |
| 81610 | ORIG | 2025-03-17 |
| 81268 | ORIG | 2025-02-18 |
| 81267 | ORIG | 2025-02-18 |
| 81265 | ORIG | 2025-02-18 |