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 |
2022/03/24 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2021/02/12 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/01/25 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/07/27 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/08/11 |
SUPPL-34(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/02/23 |
SUPPL-32(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2016/03/01 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/04/29 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/06/17 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2011/04/06 |
SUPPL-24(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2011/04/06 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/02/16 |
SUPPL-17(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/12/01 |
SUPPL-23(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2010/03/03 |
SUPPL-18(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2009/12/22 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2009/10/30 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/07/31 |
SUPPL-14(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2009/07/31 |
SUPPL-13(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2009/07/19 |
SUPPL-15(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2008/09/04 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/08/26 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2008/08/26 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2008/08/14 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/05/16 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/12/21 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/12/21 |
SUPPL-1(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2007/04/27 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/12/19 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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: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 |
Prescription |
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 |
208643 |
002 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2022/06/29
|
LUPIN LTD |
216174 |
002 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2023/08/23
|
ASCENT PHARMS INC |
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 |
Prescription |
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 |
208643 |
003 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
Prescription |
No |
No |
AB |
2022/06/29
|
LUPIN LTD |
216174 |
003 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
Prescription |
No |
No |
AB |
2023/08/23
|
ASCENT PHARMS INC |
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 |
Prescription |
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 |
208643 |
004 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
Prescription |
No |
No |
AB |
2022/06/29
|
LUPIN LTD |
216174 |
004 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
Prescription |
No |
No |
AB |
2023/08/23
|
ASCENT PHARMS INC |
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 |
021999 |
006 |
NDA |
INVEGA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
Discontinued |
Yes |
No |
AB |
2008/08/26
|
JANSSEN PHARMS |
202645 |
001 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
Prescription |
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 |
208643 |
001 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
Prescription |
No |
No |
AB |
2022/06/29
|
LUPIN LTD |
216174 |
001 |
ANDA |
PALIPERIDONE |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG |
Prescription |
No |
No |
AB |
2023/08/23
|
ASCENT PHARMS INC |