| COTEMPLA XR-ODT |
205489 |
001 |
NDA |
METHYLPHENIDATE |
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL |
8.6MG |
Yes
|
No
|
2017/06/19
|
2017/06/19
|
NEOS THERAPS INC |
Prescription |
| COTEMPLA XR-ODT |
205489 |
002 |
NDA |
METHYLPHENIDATE |
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL |
17.3MG |
Yes
|
No
|
2017/06/19
|
2017/06/19
|
NEOS THERAPS INC |
Prescription |
| COTEMPLA XR-ODT |
205489 |
003 |
NDA |
METHYLPHENIDATE |
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL |
25.9MG |
Yes
|
Yes
|
2017/06/19
|
2017/06/19
|
NEOS THERAPS INC |
Prescription |
| COTEMPLA XR-ODT |
205489 |
004 |
NDA |
METHYLPHENIDATE |
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL |
34.6MG |
Yes
|
No
|
2017/06/19
|
2024/08/19
|
NEOS THERAPS INC |
Discontinued |