0078-1021-84 |
0078-1021 |
HUMAN PRESCRIPTION DRUG |
VIJOICE |
alpelisib |
TABLET |
ORAL |
20220405 |
N/A |
NDA |
NDA215039 |
Novartis Pharmaceuticals Corporation |
ALPELISIB |
50 mg/1 |
1 BLISTER PACK in 1 CARTON (0078-1021-84) / 28 TABLET in 1 BLISTER PACK (0078-1021-51) |
0078-1021-91 |
0078-1021 |
HUMAN PRESCRIPTION DRUG |
VIJOICE |
alpelisib |
TABLET |
ORAL |
20220405 |
N/A |
NDA |
NDA215039 |
Novartis Pharmaceuticals Corporation |
ALPELISIB |
50 mg/1 |
1 BLISTER PACK in 1 CARTON (0078-1021-91) / 28 TABLET in 1 BLISTER PACK (0078-1021-90) |
0078-1028-84 |
0078-1028 |
HUMAN PRESCRIPTION DRUG |
VIJOICE |
alpelisib |
TABLET |
ORAL |
20220405 |
N/A |
NDA |
NDA215039 |
Novartis Pharmaceuticals Corporation |
ALPELISIB |
125 mg/1 |
1 BLISTER PACK in 1 CARTON (0078-1028-84) / 28 TABLET in 1 BLISTER PACK (0078-1028-51) |
0078-1028-91 |
0078-1028 |
HUMAN PRESCRIPTION DRUG |
VIJOICE |
alpelisib |
TABLET |
ORAL |
20220405 |
N/A |
NDA |
NDA215039 |
Novartis Pharmaceuticals Corporation |
ALPELISIB |
125 mg/1 |
1 BLISTER PACK in 1 CARTON (0078-1028-91) / 28 TABLET in 1 BLISTER PACK (0078-1028-90) |
0078-1035-02 |
0078-1035 |
HUMAN PRESCRIPTION DRUG |
VIJOICE |
alpelisib |
KIT |
|
20220405 |
N/A |
NDA |
NDA215039 |
Novartis Pharmaceuticals Corporation |
|
|
2 BLISTER PACK in 1 CARTON (0078-1035-02) / 1 KIT in 1 BLISTER PACK (0078-1035-61) |
0078-1035-92 |
0078-1035 |
HUMAN PRESCRIPTION DRUG |
VIJOICE |
alpelisib |
KIT |
|
20220405 |
N/A |
NDA |
NDA215039 |
Novartis Pharmaceuticals Corporation |
|
|
2 BLISTER PACK in 1 CARTON (0078-1035-92) / 1 KIT in 1 BLISTER PACK (0078-1035-94) |