DEXTROAMPHETAMINE SULFATE |
090652 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
No
|
No
|
2014/03/07
|
2014/03/07
|
EPIC PHARMA LLC |
Discontinued |
DEXTROAMPHETAMINE SULFATE |
090652 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
No
|
No
|
2014/03/07
|
2014/03/07
|
EPIC PHARMA LLC |
Discontinued |
DEXTROAMPHETAMINE SULFATE |
203548 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
No
|
No
|
2015/11/23
|
2015/11/23
|
AVANTHI INC |
Prescription |
DEXTROAMPHETAMINE SULFATE |
203548 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
No
|
No
|
2015/11/23
|
2015/11/23
|
AVANTHI INC |
Prescription |
DEXTROAMPHETAMINE SULFATE |
206735 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
5MG |
No
|
No
|
2016/01/27
|
2016/01/27
|
NORVIUM BIOSCIENCE |
Discontinued |
DEXTROAMPHETAMINE SULFATE |
206735 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG |
No
|
No
|
2016/01/27
|
2016/01/27
|
NORVIUM BIOSCIENCE |
Discontinued |
DEXTROAMPHETAMINE SULFATE |
206735 |
003 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
No
|
No
|
2016/01/27
|
2016/01/27
|
NORVIUM BIOSCIENCE |
Discontinued |
DEXTROAMPHETAMINE SULFATE |
204330 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
No
|
No
|
2016/03/16
|
2016/03/16
|
NOVEL LABS INC |
Prescription |
DEXTROAMPHETAMINE SULFATE |
204330 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
No
|
No
|
2016/03/16
|
2016/03/16
|
NOVEL LABS INC |
Prescription |
DEXTROAMPHETAMINE SULFATE |
206588 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
No
|
No
|
2016/03/28
|
2016/03/28
|
NESHER PHARMS |
Discontinued |
DEXTROAMPHETAMINE SULFATE |
206588 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
No
|
No
|
2016/03/28
|
2016/03/28
|
NESHER PHARMS |
Discontinued |
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE |
206304 |
001 |
ANDA |
DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
5MG |
No
|
No
|
2016/04/15
(TA)
|
--
|
COREPHARMA |
None (Tentative Approval) |
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE |
206304 |
002 |
ANDA |
DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG |
No
|
No
|
2016/04/15
(TA)
|
--
|
COREPHARMA |
None (Tentative Approval) |
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE |
206304 |
003 |
ANDA |
DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
No
|
No
|
2016/04/15
(TA)
|
--
|
COREPHARMA |
None (Tentative Approval) |
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE |
206304 |
004 |
ANDA |
DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
20MG |
No
|
No
|
2016/04/15
(TA)
|
--
|
COREPHARMA |
None (Tentative Approval) |
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE |
206304 |
005 |
ANDA |
DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
No
|
No
|
2016/04/15
(TA)
|
--
|
COREPHARMA |
None (Tentative Approval) |
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE |
206304 |
006 |
ANDA |
DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
30MG |
No
|
No
|
2016/04/15
(TA)
|
--
|
COREPHARMA |
None (Tentative Approval) |
DEXTROAMPHETAMINE SULFATE |
209111 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
5MG |
No
|
No
|
2017/06/27
|
2017/06/27
|
NESHER PHARMS |
Discontinued |
DEXTROAMPHETAMINE SULFATE |
209111 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG |
No
|
No
|
2017/06/27
|
2017/06/27
|
NESHER PHARMS |
Discontinued |
DEXTROAMPHETAMINE SULFATE |
209111 |
003 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
No
|
No
|
2017/06/27
|
2017/06/27
|
NESHER PHARMS |
Discontinued |