PREGABALIN |
213313 |
001 |
ANDA |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
165MG |
No
|
No
|
2021/04/13
|
2021/04/13
|
APOTEX |
Prescription |
PREGABALIN |
213313 |
002 |
ANDA |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
330MG |
No
|
No
|
2021/04/13
|
2021/04/13
|
APOTEX |
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 |
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 |
PREGABALIN |
211431 |
001 |
ANDA |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
330MG |
No
|
No
|
2021/07/02
|
2021/07/02
|
MYLAN |
Discontinued |
PREGABALIN |
211687 |
001 |
ANDA |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
82.5MG |
No
|
No
|
2021/07/06
|
2021/07/06
|
ALVOGEN |
Discontinued |
PREGABALIN |
211687 |
002 |
ANDA |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
165MG |
No
|
No
|
2021/07/06
|
2021/07/06
|
ALVOGEN |
Discontinued |
PREGABALIN |
211687 |
003 |
ANDA |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
330MG |
No
|
No
|
2021/07/06
|
2021/07/06
|
ALVOGEN |
Discontinued |
PREGABALIN |
211685 |
001 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
25MG |
No
|
No
|
2021/07/07
|
2021/07/07
|
APOTEX |
Prescription |
PREGABALIN |
211685 |
002 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
50MG |
No
|
No
|
2021/07/07
|
2021/07/07
|
APOTEX |
Prescription |
PREGABALIN |
211685 |
003 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
75MG |
No
|
No
|
2021/07/07
|
2021/07/07
|
APOTEX |
Prescription |
PREGABALIN |
211685 |
004 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
100MG |
No
|
No
|
2021/07/07
|
2021/07/07
|
APOTEX |
Prescription |
PREGABALIN |
211685 |
005 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
150MG |
No
|
No
|
2021/07/07
|
2021/07/07
|
APOTEX |
Prescription |
PREGABALIN |
211685 |
006 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
200MG |
No
|
No
|
2021/07/07
|
2021/07/07
|
APOTEX |
Prescription |