| PALIPERIDONE |
212807 |
001 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
No
|
No
|
2020/10/29
|
2020/10/29
|
CSPC OUYI |
Prescription |
| PALIPERIDONE |
212807 |
002 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
No
|
No
|
2020/10/29
|
2020/10/29
|
CSPC OUYI |
Prescription |
| PALIPERIDONE |
212807 |
003 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
No
|
No
|
2020/10/29
|
2020/10/29
|
CSPC OUYI |
Prescription |
| PALIPERIDONE |
212807 |
004 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
No
|
No
|
2020/10/29
|
2020/10/29
|
CSPC OUYI |
Prescription |
| PALIPERIDONE |
208643 |
001 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
No
|
No
|
2022/06/29
|
2022/06/29
|
LUPIN LTD |
Discontinued |
| PALIPERIDONE |
208643 |
002 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
No
|
No
|
2022/06/29
|
2022/06/29
|
LUPIN LTD |
Discontinued |
| PALIPERIDONE |
208643 |
003 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
No
|
No
|
2022/06/29
|
2022/06/29
|
LUPIN LTD |
Discontinued |
| PALIPERIDONE |
208643 |
004 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
No
|
No
|
2022/06/29
|
2022/06/29
|
LUPIN LTD |
Discontinued |
| 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 |
216174 |
001 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
No
|
No
|
2023/08/23
|
2023/08/23
|
ASCENT PHARMS INC |
Prescription |
| PALIPERIDONE |
216174 |
002 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
No
|
No
|
2023/08/23
|
2023/08/23
|
ASCENT PHARMS INC |
Prescription |
| PALIPERIDONE |
216174 |
003 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
No
|
No
|
2023/08/23
|
2023/08/23
|
ASCENT PHARMS INC |
Prescription |
| PALIPERIDONE |
216174 |
004 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
No
|
No
|
2023/08/23
|
2023/08/23
|
ASCENT PHARMS INC |
Prescription |
| 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 |
218514 |
001 |
ANDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
No
|
No
|
2024/06/26
|
2024/06/26
|
AJANTA PHARMA LTD |
Prescription |