| 219209 | NDA | VERTEX PHARMS INC | | 001 | JOURNAVX | TABLET;ORAL | 50MG | SUZETRIGINE | 2025-01-30 | Prescription | Yes |
| 218730 | NDA | VERTEX PHARMS INC | | 001 | ALYFTREK | TABLET;ORAL | 50MG;20MG;EQ 4MG BASE | DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM | 2024-12-20 | Prescription | No |
| 002 | ALYFTREK | TABLET;ORAL | 125MG;50MG;EQ 10MG BASE | DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM | 2024-12-20 | Prescription | Yes |
| 217660 | NDA | VERTEX PHARMS INC | | 001 | TRIKAFTA (COPACKAGED) | GRANULES;ORAL | 80MG, 60MG, 40MG;59.5MG | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | 2023-04-26 | Prescription | No |
| 002 | TRIKAFTA (COPACKAGED) | GRANULES;ORAL | 100MG, 75MG, 50MG;75MG | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | 2023-04-26 | Prescription | Yes |
| 212273 | NDA | VERTEX PHARMS INC | | 001 | TRIKAFTA (COPACKAGED) | TABLET;ORAL | 100MG,75MG,50MG; 150MG | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | 2019-10-21 | Prescription | Yes |
| 002 | TRIKAFTA (COPACKAGED) | TABLET;ORAL | 50MG,37.5MG,25MG; 75MG | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | 2019-10-21 | Prescription | No |
| 211358 | NDA | VERTEX PHARMS INC | | 001 | ORKAMBI | GRANULE;ORAL | 125MG/PACKET;100MG/PACKET | IVACAFTOR; LUMACAFTOR | 2018-08-07 | Prescription | No |
| 002 | ORKAMBI | GRANULE;ORAL | 188MG/PACKET;150MG/PACKET | IVACAFTOR; LUMACAFTOR | 2018-08-07 | Prescription | Yes |
| 003 | ORKAMBI | GRANULE;ORAL | 94MG/PACKET;75MG/PACKET | IVACAFTOR; LUMACAFTOR | 2018-08-07 | Prescription | No |
| 210491 | NDA | VERTEX PHARMS INC | | 001 | SYMDEKO (COPACKAGED) | TABLET;ORAL | 150MG;150MG, 100MG | IVACAFTOR; IVACAFTOR, TEZACAFTOR | 2018-02-12 | Prescription | Yes |
| 002 | SYMDEKO (COPACKAGED) | TABLET;ORAL | 75MG;75MG, 50MG | IVACAFTOR; IVACAFTOR, TEZACAFTOR | 2018-02-12 | Prescription | No |
| 206038 | NDA | VERTEX PHARMS INC | | 001 | ORKAMBI | TABLET;ORAL | 125MG;200MG | IVACAFTOR; LUMACAFTOR | 2015-07-02 | Prescription | Yes |
| 002 | ORKAMBI | TABLET;ORAL | 125MG;100MG | IVACAFTOR; LUMACAFTOR | 2015-07-02 | Prescription | No |
| 207925 | NDA | VERTEX PHARMS INC | | 001 | KALYDECO | GRANULE;ORAL | 50MG/PACKET | IVACAFTOR | 2015-03-17 | Prescription | No |
| 002 | KALYDECO | GRANULE;ORAL | 75MG/PACKET | IVACAFTOR | 2015-03-17 | Prescription | Yes |
| 003 | KALYDECO | GRANULE;ORAL | 25MG/PACKET | IVACAFTOR | 2015-03-17 | Prescription | No |
| 004 | KALYDECO | GRANULE;ORAL | 5.8MG/PACKET | IVACAFTOR | 2015-03-17 | Prescription | No |
| 005 | KALYDECO | GRANULE;ORAL | 13.4MG/PACKET | IVACAFTOR | 2015-03-17 | Prescription | No |
| 203188 | NDA | VERTEX PHARMS | | 001 | KALYDECO | TABLET;ORAL | 150MG | IVACAFTOR | 2012-01-31 | Prescription | Yes |
| 201917 | NDA | VERTEX PHARMS | | 001 | INCIVEK | TABLET;ORAL | 375MG | TELAPREVIR | 2011-05-23 | Discontinued | No |