Skip to contentApplication 218490
- Type
- NDA
- Sponsor
- ACTELION
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OPSYNVI | MACITENTAN; TADALAFIL | TABLET;ORAL | 10MG;20MG | Yes | No |
| 002 | OPSYNVI | MACITENTAN; TADALAFIL | TABLET;ORAL | 10MG;40MG | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81891 | SUPPL | 2025-04-08 |
| 81822 | SUPPL | 2025-04-03 |
| 80567 | SUPPL | 2024-12-13 |
| 79983 | ORIG | 2024-10-25 |
| 77958 | ORIG | 2024-03-25 |
| 77957 | ORIG | 2024-03-25 |
| 77953 | ORIG | 2024-03-25 |