LYBALVI |
213378 |
001 |
NDA |
OLANZAPINE; SAMIDORPHAN L-MALATE |
TABLET;ORAL |
5MG;EQ 10MG BASE |
Yes
|
Yes
|
2021/05/28
|
2021/05/28
|
ALKERMES INC |
Prescription |
LYBALVI |
213378 |
001 |
NDA |
OLANZAPINE; SAMIDORPHAN L-MALATE |
TABLET;ORAL |
5MG;EQ 10MG BASE |
Yes
|
Yes
|
2021/05/28
|
2021/05/28
|
ALKERMES INC |
Prescription |
LYBALVI |
213378 |
002 |
NDA |
OLANZAPINE; SAMIDORPHAN L-MALATE |
TABLET;ORAL |
10MG;EQ 10MG BASE |
Yes
|
No
|
2021/05/28
|
2021/05/28
|
ALKERMES INC |
Prescription |
LYBALVI |
213378 |
002 |
NDA |
OLANZAPINE; SAMIDORPHAN L-MALATE |
TABLET;ORAL |
10MG;EQ 10MG BASE |
Yes
|
No
|
2021/05/28
|
2021/05/28
|
ALKERMES INC |
Prescription |
LYBALVI |
213378 |
003 |
NDA |
OLANZAPINE; SAMIDORPHAN L-MALATE |
TABLET;ORAL |
15MG;EQ 10MG BASE |
Yes
|
No
|
2021/05/28
|
2021/05/28
|
ALKERMES INC |
Prescription |
LYBALVI |
213378 |
003 |
NDA |
OLANZAPINE; SAMIDORPHAN L-MALATE |
TABLET;ORAL |
15MG;EQ 10MG BASE |
Yes
|
No
|
2021/05/28
|
2021/05/28
|
ALKERMES INC |
Prescription |
LYBALVI |
213378 |
004 |
NDA |
OLANZAPINE; SAMIDORPHAN L-MALATE |
TABLET;ORAL |
20MG;EQ 10MG BASE |
Yes
|
No
|
2021/05/28
|
2021/05/28
|
ALKERMES INC |
Prescription |
LYBALVI |
213378 |
004 |
NDA |
OLANZAPINE; SAMIDORPHAN L-MALATE |
TABLET;ORAL |
20MG;EQ 10MG BASE |
Yes
|
No
|
2021/05/28
|
2021/05/28
|
ALKERMES INC |
Prescription |