51167-400-01 |
51167-400 |
HUMAN PRESCRIPTION DRUG |
Kalydeco |
ivacaftor |
GRANULE |
ORAL |
20150323 |
N/A |
NDA |
NDA207925 |
Vertex Pharmaceuticals Incorporated |
IVACAFTOR |
75 mg/1 |
56 GRANULE in 1 CARTON (51167-400-01) |
51167-600-01 |
51167-600 |
HUMAN PRESCRIPTION DRUG |
Kalydeco |
ivacaftor |
GRANULE |
ORAL |
20190429 |
N/A |
NDA |
NDA207925 |
Vertex Pharmaceuticals Incorporated |
IVACAFTOR |
25 mg/1 |
56 GRANULE in 1 CARTON (51167-600-01) |
51167-785-01 |
51167-785 |
HUMAN PRESCRIPTION DRUG |
Kalydeco |
ivacaftor |
GRANULE |
ORAL |
20230503 |
N/A |
NDA |
NDA207925 |
Vertex Pharmaceuticals Incorporated |
IVACAFTOR |
5.8 mg/1 |
56 GRANULE in 1 CARTON (51167-785-01) |
51167-770-01 |
51167-770 |
HUMAN PRESCRIPTION DRUG |
Kalydeco |
ivacaftor |
GRANULE |
ORAL |
20230503 |
N/A |
NDA |
NDA207925 |
Vertex Pharmaceuticals Incorporated |
IVACAFTOR |
13.4 mg/1 |
56 GRANULE in 1 CARTON (51167-770-01) |
51167-300-01 |
51167-300 |
HUMAN PRESCRIPTION DRUG |
Kalydeco |
ivacaftor |
GRANULE |
ORAL |
20150323 |
N/A |
NDA |
NDA207925 |
Vertex Pharmaceuticals Incorporated |
IVACAFTOR |
50 mg/1 |
56 GRANULE in 1 CARTON (51167-300-01) |