| DYANAVEL XR |
208147 |
001 |
NDA |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
SUSPENSION, EXTENDED RELEASE;ORAL |
2MG/ML;EQ 0.5MG BASE/ML |
Yes
|
Yes
|
2015/10/19
|
2015/10/19
|
TRIS PHARMA INC |
Prescription |
| DYANAVEL XR 5 |
210526 |
001 |
NDA |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TABLET, EXTENDED RELEASE;ORAL |
4MG;EQ 1MG BASE |
Yes
|
No
|
2021/11/04
|
2021/11/04
|
TRIS PHARMA INC |
Prescription |
| DYANAVEL XR 10 |
210526 |
002 |
NDA |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TABLET, EXTENDED RELEASE;ORAL |
8MG;EQ 2MG BASE |
Yes
|
No
|
2021/11/04
|
2021/11/04
|
TRIS PHARMA INC |
Prescription |
| DYANAVEL XR 15 |
210526 |
003 |
NDA |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TABLET, EXTENDED RELEASE;ORAL |
12MG;EQ 3MG BASE |
Yes
|
No
|
2021/11/04
|
2021/11/04
|
TRIS PHARMA INC |
Prescription |
| DYANAVEL XR 20 |
210526 |
004 |
NDA |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TABLET, EXTENDED RELEASE;ORAL |
16MG;EQ 4MG BASE |
Yes
|
Yes
|
2021/11/04
|
2021/11/04
|
TRIS PHARMA INC |
Prescription |