DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
217027 |
004 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
5MG;5MG;5MG;5MG |
No
|
No
|
2023/01/23
|
2023/01/23
|
GRANULES |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
217027 |
005 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
6.25MG;6.25MG;6.25MG;6.25MG |
No
|
No
|
2023/01/23
|
2023/01/23
|
GRANULES |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
217027 |
006 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
7.5MG;7.5MG;7.5MG;7.5MG |
No
|
No
|
2023/01/23
|
2023/01/23
|
GRANULES |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
211546 |
001 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
3.125MG;3.125MG;3.125MG;3.125MG |
No
|
No
|
2023/08/31
|
2023/08/31
|
SPECGX LLC |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
211546 |
002 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
6.25MG;6.25MG;6.25MG;6.25MG |
No
|
No
|
2023/08/31
|
2023/08/31
|
SPECGX LLC |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
211546 |
003 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
9.375MG;9.375MG;9.375MG;9.375MG |
No
|
No
|
2023/08/31
|
2023/08/31
|
SPECGX LLC |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
211546 |
004 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
12.5MG;12.5MG;12.5MG;12.5MG |
No
|
No
|
2023/08/31
|
2023/08/31
|
SPECGX LLC |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
215997 |
001 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
3.125MG;3.125MG;3.125MG;3.125MG |
No
|
No
|
2023/09/27
|
2023/09/27
|
SUN PHARM INDS INC |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
215997 |
002 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
6.25MG;6.25MG;6.25MG;6.25MG |
No
|
No
|
2023/09/27
|
2023/09/27
|
SUN PHARM INDS INC |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
215997 |
003 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
9.375MG;9.375MG;9.375MG;9.375MG |
No
|
No
|
2023/09/27
|
2023/09/27
|
SUN PHARM INDS INC |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
215997 |
004 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
12.5MG;12.5MG;12.5MG;12.5MG |
No
|
No
|
2023/09/27
|
2023/09/27
|
SUN PHARM INDS INC |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
217787 |
001 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
1.25MG;1.25MG;1.25MG;1.25MG |
No
|
No
|
2023/10/06
|
2023/10/06
|
ALKEM LABS LTD |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
217787 |
002 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
1.875MG;1.875MG;1.875MG;1.875MG |
No
|
No
|
2023/10/06
|
2023/10/06
|
ALKEM LABS LTD |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
217787 |
003 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
2.5MG;2.5MG;2.5MG;2.5MG |
No
|
No
|
2023/10/06
|
2023/10/06
|
ALKEM LABS LTD |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
217787 |
004 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
3.125MG;3.125MG;3.125MG;3.125MG |
No
|
No
|
2023/10/06
|
2023/10/06
|
ALKEM LABS LTD |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
217787 |
005 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
3.75MG;3.75MG;3.75MG;3.75MG |
No
|
No
|
2023/10/06
|
2023/10/06
|
ALKEM LABS LTD |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
217787 |
006 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
5MG;5MG;5MG;5MG |
No
|
No
|
2023/10/06
|
2023/10/06
|
ALKEM LABS LTD |
Prescription |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
217787 |
007 |
ANDA |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
7.5MG;7.5MG;7.5MG;7.5MG |
No
|
No
|
2023/10/06
|
2023/10/06
|
ALKEM LABS LTD |
Prescription |