Application 212273
- 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 | TABLET, TABLET;ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | Yes | Yes |
| 002 | TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TABLET;ORAL | 50MG,37.5MG,25MG; 75MG | Yes | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51167-106 | Trikafta | Elexacaftor, Tezacaftor, and Ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-106 | Trikafta | Elexacaftor, Tezacaftor, and Ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-106 | Trikafta | Elexacaftor, Tezacaftor, and Ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-331 | Trikafta | Elexacaftor, Tezacaftor, and Ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-331 | Trikafta | Elexacaftor, Tezacaftor, and Ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-331 | Trikafta | Elexacaftor, Tezacaftor, and Ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-331 | Trikafta | Elexacaftor, Tezacaftor, and Ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-331 | Trikafta | Elexacaftor, Tezacaftor, and Ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-331 | Trikafta | Elexacaftor, Tezacaftor, and Ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-331 | Trikafta | Elexacaftor, Tezacaftor, and Ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85896 | SUPPL | 2026-05-13 |
| 85659 | SUPPL | 2026-04-09 |
| 85582 | SUPPL | 2026-03-30 |
| 85478 | SUPPL | 2026-03-24 |
| 85413 | SUPPL | 2026-03-19 |
| 83562 | SUPPL | 2025-09-26 |
| 83551 | SUPPL | 2025-09-26 |
| 81653 | SUPPL | 2025-07-25 |
| 81651 | SUPPL | 2025-07-25 |
| 81647 | SUPPL | 2025-07-25 |
| 81646 | SUPPL | 2025-07-25 |
| 74997 | SUPPL | 2023-08-04 |
| 74983 | SUPPL | 2023-08-04 |
| 74101 | SUPPL | 2023-04-27 |
| 74089 | SUPPL | 2023-04-27 |
| 68893 | SUPPL | 2021-10-06 |
| 68877 | SUPPL | 2021-10-05 |
| 67752 | SUPPL | 2021-06-09 |
| 67749 | SUPPL | 2021-06-09 |
| 65745 | SUPPL | 2020-12-28 |
| 65725 | SUPPL | 2020-12-23 |
| 65295 | SUPPL | 2020-11-19 |
| 65280 | SUPPL | 2020-11-19 |
| 61040 | ORIG | 2019-11-25 |
| 60631 | ORIG | 2019-10-22 |
| 60624 | ORIG | 2019-10-22 |