MYDAYIS |
022063 |
001 |
NDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
3.125MG;3.125MG;3.125MG;3.125MG |
Yes
|
No
|
2017/06/20
|
2017/06/20
|
TAKEDA PHARMS USA |
Prescription |
MYDAYIS |
022063 |
002 |
NDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
6.25MG;6.25MG;6.25MG;6.25MG |
Yes
|
No
|
2017/06/20
|
2017/06/20
|
TAKEDA PHARMS USA |
Prescription |
MYDAYIS |
022063 |
003 |
NDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
9.375MG;9.375MG;9.375MG;9.375MG |
Yes
|
No
|
2017/06/20
|
2017/06/20
|
TAKEDA PHARMS USA |
Prescription |
MYDAYIS |
022063 |
004 |
NDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
12.5MG;12.5MG;12.5MG;12.5MG |
Yes
|
Yes
|
2017/06/20
|
2017/06/20
|
TAKEDA PHARMS USA |
Prescription |