TRINTELLIX |
204447 |
001 |
NDA |
VORTIOXETINE HYDROBROMIDE |
TABLET;ORAL |
EQ 5MG BASE |
Yes
|
No
|
2013/09/30
|
2013/09/30
|
TAKEDA PHARMS USA |
Prescription |
TRINTELLIX |
204447 |
002 |
NDA |
VORTIOXETINE HYDROBROMIDE |
TABLET;ORAL |
EQ 10MG BASE |
Yes
|
No
|
2013/09/30
|
2013/09/30
|
TAKEDA PHARMS USA |
Prescription |
TRINTELLIX |
204447 |
003 |
NDA |
VORTIOXETINE HYDROBROMIDE |
TABLET;ORAL |
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2013/09/30
|
2013/09/30
|
TAKEDA PHARMS USA |
Discontinued |
TRINTELLIX |
204447 |
004 |
NDA |
VORTIOXETINE HYDROBROMIDE |
TABLET;ORAL |
EQ 20MG BASE |
Yes
|
Yes
|
2013/09/30
|
2013/09/30
|
TAKEDA PHARMS USA |
Prescription |