| TRIKAFTA (COPACKAGED) |
212273 |
001 |
NDA |
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR |
TABLET;ORAL |
100MG,75MG,50MG; 150MG |
Yes
|
Yes
|
2019/10/21
|
2019/10/21
|
VERTEX PHARMS INC |
Prescription |
| TRIKAFTA (COPACKAGED) |
212273 |
002 |
NDA |
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR |
TABLET;ORAL |
50MG,37.5MG,25MG; 75MG |
Yes
|
No
|
2019/10/21
|
2021/06/08
|
VERTEX PHARMS INC |
Prescription |
| TRIKAFTA (COPACKAGED) |
217660 |
001 |
NDA |
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR |
GRANULES;ORAL |
80MG, 60MG, 40MG;59.5MG |
Yes
|
No
|
2023/04/26
|
2023/04/26
|
VERTEX PHARMS INC |
Prescription |
| TRIKAFTA (COPACKAGED) |
217660 |
002 |
NDA |
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR |
GRANULES;ORAL |
100MG, 75MG, 50MG;75MG |
Yes
|
Yes
|
2023/04/26
|
2023/04/26
|
VERTEX PHARMS INC |
Prescription |