Vertex Pharmaceuticals Incorporated (VRTX)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| NDA217660 - VERTEX PHARMS INC | |||||||
| TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | GRANULES;ORAL | 80MG, 60MG, 40MG;59.5MG | Prescription | |||
| TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | GRANULES;ORAL | 100MG, 75MG, 50MG;75MG | Prescription | |||
| NDA212273 - VERTEX PHARMS INC | |||||||
| TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TABLET;ORAL | 100MG,75MG,50MG; 150MG | Prescription | |||
| TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TABLET;ORAL | 50MG,37.5MG,25MG; 75MG | Prescription | |||
| NDA211358 - VERTEX PHARMS INC | |||||||
| ORKAMBI | IVACAFTOR; LUMACAFTOR | GRANULE;ORAL | 125MG/PACKET;100MG/PACKET | Prescription | |||
| ORKAMBI | IVACAFTOR; LUMACAFTOR | GRANULE;ORAL | 188MG/PACKET;150MG/PACKET | Prescription | |||
| ORKAMBI | IVACAFTOR; LUMACAFTOR | GRANULE;ORAL | 94MG/PACKET;75MG/PACKET | Prescription | |||
| NDA210491 - VERTEX PHARMS INC | |||||||
| SYMDEKO (COPACKAGED) | IVACAFTOR; IVACAFTOR, TEZACAFTOR | TABLET;ORAL | 150MG;150MG, 100MG | Prescription | |||
| SYMDEKO (COPACKAGED) | IVACAFTOR; IVACAFTOR, TEZACAFTOR | TABLET;ORAL | 75MG;75MG, 50MG | Prescription | |||
| NDA207925 - VERTEX PHARMS INC | |||||||
| KALYDECO | IVACAFTOR | GRANULE;ORAL | 25MG/PACKET | Prescription | |||
| KALYDECO | IVACAFTOR | GRANULE;ORAL | 75MG/PACKET | Prescription | |||
| KALYDECO | IVACAFTOR | GRANULE;ORAL | 13.4MG/PACKET | Prescription | |||
| KALYDECO | IVACAFTOR | GRANULE;ORAL | 5.8MG/PACKET | Prescription | |||
| KALYDECO | IVACAFTOR | GRANULE;ORAL | 50MG/PACKET | Prescription | |||
| NDA206038 - VERTEX PHARMS INC | |||||||
| ORKAMBI | IVACAFTOR; LUMACAFTOR | TABLET;ORAL | 125MG;100MG | Prescription | |||
| ORKAMBI | IVACAFTOR; LUMACAFTOR | TABLET;ORAL | 125MG;200MG | Prescription | |||
| NDA203188 - VERTEX PHARMS | |||||||
| KALYDECO | IVACAFTOR | TABLET;ORAL | 150MG | Prescription | |||
| NDA201917 - VERTEX PHARMS | |||||||
| INCIVEK | TELAPREVIR | TABLET;ORAL | 375MG | Discontinued | |||