| PALIPERIDONE PALMITATE |
216674 |
003 |
ANDA |
PALIPERIDONE PALMITATE |
INJECTABLE; SUSPENSION, EXTENDED RELEASE |
117MG |
No
|
No
|
2025/05/16
(TA)
|
--
|
ACCORD HLTHCARE INC |
None (Tentative Approval) |
| PALIPERIDONE PALMITATE |
216674 |
004 |
ANDA |
PALIPERIDONE PALMITATE |
INJECTABLE; SUSPENSION, EXTENDED RELEASE |
78MG |
No
|
No
|
2025/05/16
(TA)
|
--
|
ACCORD HLTHCARE INC |
None (Tentative Approval) |
| PALIPERIDONE PALMITATE |
216674 |
005 |
ANDA |
PALIPERIDONE PALMITATE |
INJECTABLE; SUSPENSION, EXTENDED RELEASE |
39MG |
No
|
No
|
2025/05/16
(TA)
|
--
|
ACCORD HLTHCARE INC |
None (Tentative Approval) |
| PALIPERIDONE |
218755 |
001 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
No
|
No
|
2025/09/04
|
2025/09/04
|
EVEREST LIFESCIENCES |
Prescription |
| PALIPERIDONE |
218755 |
002 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
No
|
No
|
2025/09/04
|
2025/09/04
|
EVEREST LIFESCIENCES |
Prescription |
| PALIPERIDONE |
218755 |
003 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
No
|
No
|
2025/09/04
|
2025/09/04
|
EVEREST LIFESCIENCES |
Prescription |
| PALIPERIDONE |
218755 |
004 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
No
|
No
|
2025/09/04
|
2025/09/04
|
EVEREST LIFESCIENCES |
Prescription |