| PALIPERIDONE PALMITATE |
211995 |
001 |
ANDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
39MG/0.25ML |
No
|
No
|
2023/06/30
(TA)
|
--
|
TOLMAR |
None (Tentative Approval) |
| PALIPERIDONE PALMITATE |
211995 |
002 |
ANDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
78MG/0.5ML |
No
|
No
|
2023/06/30
(TA)
|
--
|
TOLMAR |
None (Tentative Approval) |
| PALIPERIDONE PALMITATE |
211995 |
003 |
ANDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
117MG/0.75ML |
No
|
No
|
2023/06/30
(TA)
|
--
|
TOLMAR |
None (Tentative Approval) |
| PALIPERIDONE PALMITATE |
211995 |
004 |
ANDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
156MG/ML |
No
|
No
|
2023/06/30
(TA)
|
--
|
TOLMAR |
None (Tentative Approval) |
| PALIPERIDONE PALMITATE |
211995 |
005 |
ANDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
234MG/1.5ML |
No
|
No
|
2023/06/30
(TA)
|
--
|
TOLMAR |
None (Tentative Approval) |
| PALIPERIDONE PALMITATE |
210397 |
001 |
ANDA |
PALIPERIDONE PALMITATE |
SUSPENSION;EXTENDED RELEASE |
|
No
|
No
|
2024/02/05
(TA)
|
--
|
PHARMASCIENCE INC |
None (Tentative Approval) |
| PALIPERIDONE PALMITATE |
216228 |
001 |
ANDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INJECTABLE |
273MG/0.88ML |
No
|
No
|
2024/05/20
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| 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 PALMITATE |
216674 |
002 |
ANDA |
PALIPERIDONE PALMITATE |
INJECTABLE; SUSPENSION, EXTENDED RELEASE |
156MG |
No
|
No
|
2025/05/16
(TA)
|
--
|
ACCORD HLTHCARE INC |
None (Tentative Approval) |
| 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) |