批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|
| 2024/06/26 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|
| 无 |
与本品治疗等效的药品
活性成分:PALIPERIDONE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:1.5MG 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 202645 |
001 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
Discontinued |
No |
No |
AB |
2015/08/03
|
ACTAVIS LABS FL INC |
| 203802 |
001 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
Prescription |
No |
No |
AB |
2015/09/24
|
RK PHARMA |
| 205618 |
001 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5mg |
Prescription |
No |
No |
AB |
2018/04/06
|
SUN PHARM |
| 204452 |
001 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
Prescription |
No |
No |
AB |
2019/06/12
|
INVENTIA |
| 204707 |
001 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
Prescription |
No |
No |
AB |
2019/09/23
|
AMNEAL PHARMS |
| 212807 |
001 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
Prescription |
No |
No |
AB |
2020/10/29
|
CSPC OUYI |
| 216174 |
001 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
Prescription |
No |
No |
AB |
2023/08/23
|
ASCENT PHARMS INC |
| 218514 |
001 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
Prescription |
No |
No |
AB |
2024/06/26
|
AJANTA PHARMA LTD |
| 218330 |
001 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
Prescription |
No |
No |
AB |
2024/09/26
|
ALEMBIC |
| 217445 |
001 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
Prescription |
No |
No |
AB |
2024/10/08
|
ZYDUS PHARMS |
活性成分:PALIPERIDONE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:3MG 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 021999 |
001 |
NDA |
INVEGA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
Yes |
No |
AB |
2006/12/19
|
JANSSEN PHARMS |
| 202645 |
002 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Discontinued |
No |
No |
AB |
2015/08/03
|
ACTAVIS LABS FL INC |
| 203802 |
002 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2015/09/24
|
RK PHARMA |
| 205618 |
002 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2018/04/06
|
SUN PHARM |
| 204452 |
002 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2019/06/12
|
INVENTIA |
| 204707 |
002 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2019/09/23
|
AMNEAL PHARMS |
| 212807 |
002 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2020/10/29
|
CSPC OUYI |
| 216174 |
002 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2023/08/23
|
ASCENT PHARMS INC |
| 218514 |
002 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2024/06/26
|
AJANTA PHARMA LTD |
| 218330 |
002 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2024/09/26
|
ALEMBIC |
| 217445 |
002 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2024/10/08
|
ZYDUS PHARMS |
活性成分:PALIPERIDONE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:6MG 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 021999 |
002 |
NDA |
INVEGA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
Prescription |
Yes |
Yes |
AB |
2006/12/19
|
JANSSEN PHARMS |
| 202645 |
003 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
Discontinued |
No |
No |
AB |
2015/08/03
|
ACTAVIS LABS FL INC |
| 203802 |
003 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
Prescription |
No |
No |
AB |
2015/09/24
|
RK PHARMA |
| 205618 |
003 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
Prescription |
No |
No |
AB |
2018/04/06
|
SUN PHARM |
| 204452 |
003 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
Prescription |
No |
No |
AB |
2019/06/12
|
INVENTIA |
| 204707 |
003 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
Prescription |
No |
No |
AB |
2019/09/23
|
AMNEAL PHARMS |
| 212807 |
003 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
Prescription |
No |
No |
AB |
2020/10/29
|
CSPC OUYI |
| 216174 |
003 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
Prescription |
No |
No |
AB |
2023/08/23
|
ASCENT PHARMS INC |
| 218514 |
003 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
Prescription |
No |
No |
AB |
2024/06/26
|
AJANTA PHARMA LTD |
| 218330 |
003 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
Prescription |
No |
No |
AB |
2024/09/26
|
ALEMBIC |
| 217445 |
003 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
Prescription |
No |
No |
AB |
2024/10/08
|
ZYDUS PHARMS |
活性成分:PALIPERIDONE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:9MG 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 021999 |
003 |
NDA |
INVEGA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
Prescription |
Yes |
No |
AB |
2006/12/19
|
JANSSEN PHARMS |
| 202645 |
004 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
Discontinued |
No |
No |
AB |
2015/08/03
|
ACTAVIS LABS FL INC |
| 203802 |
004 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
Prescription |
No |
No |
AB |
2015/09/24
|
RK PHARMA |
| 205618 |
004 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
Prescription |
No |
No |
AB |
2018/04/06
|
SUN PHARM |
| 204452 |
004 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
Prescription |
No |
No |
AB |
2019/06/12
|
INVENTIA |
| 204707 |
004 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
Prescription |
No |
No |
AB |
2019/09/23
|
AMNEAL PHARMS |
| 212807 |
004 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
Prescription |
No |
No |
AB |
2020/10/29
|
CSPC OUYI |
| 216174 |
004 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
Prescription |
No |
No |
AB |
2023/08/23
|
ASCENT PHARMS INC |
| 218514 |
004 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
Prescription |
No |
No |
AB |
2024/06/26
|
AJANTA PHARMA LTD |
| 218330 |
004 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
Prescription |
No |
No |
AB |
2024/09/26
|
ALEMBIC |
| 217445 |
004 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
Prescription |
No |
No |
AB |
2024/10/08
|
ZYDUS PHARMS |