Application 217660
- Type
- NDA
- Sponsor
- VERTEX PHARMS INC
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | GRANULE;ORAL | 80MG, 60MG, 40MG;59.5MG | Yes | No |
| 002 | TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | GRANULE;ORAL | 100MG, 75MG, 50MG;75MG | Yes | Yes |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85897 | SUPPL | 2026-05-13 |
| 85660 | SUPPL | 2026-04-09 |
| 85584 | SUPPL | 2026-03-30 |
| 85479 | SUPPL | 2026-03-24 |
| 85417 | SUPPL | 2026-03-19 |
| 81652 | SUPPL | 2025-07-25 |
| 81650 | SUPPL | 2025-07-25 |
| 81649 | SUPPL | 2025-07-25 |
| 81648 | SUPPL | 2025-07-25 |
| 76516 | ORIG | 2023-11-07 |
| 74998 | SUPPL | 2023-08-04 |
| 74984 | SUPPL | 2023-08-04 |
| 74098 | ORIG | 2023-04-27 |
| 74090 | ORIG | 2023-04-27 |