| PALIPERIDONE |
218514 |
002 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
No
|
No
|
2024/06/26
|
2024/06/26
|
AJANTA PHARMA LTD |
Discontinued |
| PALIPERIDONE |
218514 |
003 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
No
|
No
|
2024/06/26
|
2024/06/26
|
AJANTA PHARMA LTD |
Discontinued |
| PALIPERIDONE |
218514 |
004 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
No
|
No
|
2024/06/26
|
2024/06/26
|
AJANTA PHARMA LTD |
Discontinued |
| PALIPERIDONE |
218330 |
001 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
No
|
No
|
2024/09/26
|
2024/09/26
|
ALEMBIC |
Prescription |
| PALIPERIDONE |
218330 |
002 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
No
|
No
|
2024/09/26
|
2024/09/26
|
ALEMBIC |
Prescription |
| PALIPERIDONE |
218330 |
003 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
No
|
No
|
2024/09/26
|
2024/09/26
|
ALEMBIC |
Prescription |
| PALIPERIDONE |
218330 |
004 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
No
|
No
|
2024/09/26
|
2024/09/26
|
ALEMBIC |
Prescription |
| PALIPERIDONE |
217445 |
001 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
No
|
No
|
2024/10/08
|
2024/10/08
|
ZYDUS PHARMS |
Prescription |
| PALIPERIDONE |
217445 |
002 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
No
|
No
|
2024/10/08
|
2024/10/08
|
ZYDUS PHARMS |
Prescription |
| PALIPERIDONE |
217445 |
003 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
No
|
No
|
2024/10/08
|
2024/10/08
|
ZYDUS PHARMS |
Prescription |
| PALIPERIDONE |
217445 |
004 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
No
|
No
|
2024/10/08
|
2024/10/08
|
ZYDUS PHARMS |
Prescription |
| PALIPERIDONE PALMITATE |
215682 |
002 |
ANDA |
PALIPERIDONE PALMITATE |
INJECTION;SUSPENSION |
410MG/1.315ML |
No
|
No
|
2024/12/03
(TA)
|
--
|
MYLAN PHARMACEUTICALS INC A VIATRIS CO |
None (Tentative Approval) |
| PALIPERIDONE PALMITATE |
215682 |
003 |
ANDA |
PALIPERIDONE PALMITATE |
INJECTION;SUSPENSION |
546MG/1.75ML |
No
|
No
|
2024/12/03
(TA)
|
--
|
MYLAN PHARMACEUTICALS INC A VIATRIS CO |
None (Tentative Approval) |
| PALIPERIDONE PALMITATE |
215682 |
004 |
ANDA |
PALIPERIDONE PALMITATE |
INJECTION;SUSPENSION |
819MG/2.625ML |
No
|
No
|
2024/12/03
(TA)
|
--
|
MYLAN PHARMACEUTICALS INC A VIATRIS CO |
None (Tentative Approval) |
| PALIPERIDONE PALMITATE |
215682 |
005 |
ANDA |
PALIPERIDONE PALMITATE |
INJECTION;SUSPENSION |
1092MG/3.5ML |
No
|
No
|
2024/12/03
(TA)
|
--
|
MYLAN PHARMACEUTICALS INC A VIATRIS CO |
None (Tentative Approval) |
| PALIPERIDONE PALMITATE |
215682 |
006 |
ANDA |
PALIPERIDONE PALMITATE |
INJECTION;SUSPENSION |
1560MG/5.0ML |
No
|
No
|
2024/12/03
(TA)
|
--
|
MYLAN PHARMACEUTICALS INC A VIATRIS CO |
None (Tentative Approval) |
| PALIPERIDONE |
205559 |
001 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
No
|
No
|
2025/02/19
|
2025/02/19
|
DR REDDYS |
Prescription |
| PALIPERIDONE |
205559 |
002 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
No
|
No
|
2025/02/19
|
2025/02/19
|
DR REDDYS |
Prescription |
| PALIPERIDONE |
205559 |
003 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
No
|
No
|
2025/02/19
|
2025/02/19
|
DR REDDYS |
Prescription |
| PALIPERIDONE PALMITATE |
216674 |
002 |
ANDA |
PALIPERIDONE PALMITATE |
INJECTABLE; SUSPENSION, EXTENDED RELEASE |
156MG |
No
|
No
|
2025/05/16
(TA)
|
--
|
ACCORD HLTHCARE INC |
None (Tentative Approval) |