药品注册申请号：021999
申请类型：NDA (新药申请)
申请人：JANSSEN PHARMS
申请人全名：JANSSEN PHARMACEUTICALS INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 INVEGA PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 3MG Yes No AB 2006/12/19 2006/12/19 Prescription
002 INVEGA PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 6MG Yes Yes AB 2006/12/19 Prescription
003 INVEGA PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 9MG Yes No AB 2006/12/19 Prescription
004 INVEGA PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2006/12/19 Discontinued
006 INVEGA PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2008/08/26 Discontinued
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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2006/12/19 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/01/23 SUPPL-41（补充） Approval Labeling-Package Insert STANDARD
2025/01/23 SUPPL-40（补充） Approval Labeling-Package Insert STANDARD
2022/03/24 SUPPL-39（补充） Approval STANDARD
2021/02/12 SUPPL-37（补充） Approval Labeling-Package Insert STANDARD
2019/01/25 SUPPL-36（补充） Approval Labeling-Package Insert STANDARD
2018/07/27 SUPPL-35（补充） Approval Labeling-Package Insert STANDARD
2017/08/11 SUPPL-34（补充） Approval Labeling-Package Insert STANDARD
2017/02/23 SUPPL-32（补充） Approval Labeling-Package Insert 901 REQUIRED
2016/03/01 SUPPL-30（补充） Approval Labeling-Package Insert STANDARD
2014/04/29 SUPPL-29（补充） Approval Labeling-Package Insert STANDARD
2013/06/17 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
2011/04/06 SUPPL-24（补充） Approval Efficacy-Pediatric PRIORITY
2011/04/06 SUPPL-20（补充） Approval Labeling-Package Insert STANDARD
2011/02/16 SUPPL-17（补充） Approval Labeling-Patient Package Insert UNKNOWN
2010/12/01 SUPPL-23（补充） Approval Labeling 901 REQUIRED
2010/03/03 SUPPL-18（补充） Approval Labeling-Package Insert 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-New Indication PRIORITY
2009/07/31 SUPPL-13（补充） Approval Efficacy-New Indication 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 Labeling-Container/Carton Labels,Labeling-Package Insert 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-Labeling Change With Clinical Data UNKNOWN
2007/04/27 SUPPL-3（补充） Approval Labeling 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
001 5158952 2009/10/27 Y U-90 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5158952 2009/10/27 Y U-90 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5158952 2009/10/27 Y U-90 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5158952 2009/10/27 Y U-90 PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
001 I-531 2010/04/27**本条是由Drugfuture回溯的历史信息**
NCE 2011/12/19**本条是由Drugfuture回溯的历史信息**
NPP 2014/04/06**本条是由Drugfuture回溯的历史信息**
PED 2014/10/06**本条是由Drugfuture回溯的历史信息**
002 I-531 2010/04/27**本条是由Drugfuture回溯的历史信息**
NCE 2011/12/19**本条是由Drugfuture回溯的历史信息**
NPP 2014/04/06**本条是由Drugfuture回溯的历史信息**
PED 2014/10/06**本条是由Drugfuture回溯的历史信息**
003 I-531 2010/04/27**本条是由Drugfuture回溯的历史信息**
NCE 2011/12/19**本条是由Drugfuture回溯的历史信息**
NPP 2014/04/06**本条是由Drugfuture回溯的历史信息**
PED 2014/10/06**本条是由Drugfuture回溯的历史信息**
004 I-531 2010/04/27**本条是由Drugfuture回溯的历史信息**
NCE 2011/12/19**本条是由Drugfuture回溯的历史信息**
NPP 2014/04/06**本条是由Drugfuture回溯的历史信息**
PED 2014/10/06**本条是由Drugfuture回溯的历史信息**
006 I-531 2010/04/27**本条是由Drugfuture回溯的历史信息**
NCE 2011/12/19**本条是由Drugfuture回溯的历史信息**
NPP 2014/04/06**本条是由Drugfuture回溯的历史信息**
PED 2014/10/06**本条是由Drugfuture回溯的历史信息**
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RLDRSTE 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 Discontinued 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
205559 001 ANDA PALIPERIDONE PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 3MG Prescription No No AB 2025/02/19 DR REDDYS
218755 002 ANDA PALIPERIDONE PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 3MG Prescription No No AB 2025/09/04 EVEREST LIFESCIENCES
>>>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RLDRSTE 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 Discontinued 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
205559 002 ANDA PALIPERIDONE PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 6MG Prescription No No AB 2025/02/19 DR REDDYS
218755 003 ANDA PALIPERIDONE PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 6MG Prescription No No AB 2025/09/04 EVEREST LIFESCIENCES
>>>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RLDRSTE 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 Discontinued 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
205559 003 ANDA PALIPERIDONE PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 9MG Prescription No No AB 2025/02/19 DR REDDYS
218755 004 ANDA PALIPERIDONE PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 9MG Prescription No No AB 2025/09/04 EVEREST LIFESCIENCES
>>>活性成分:PALIPERIDONE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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RLDRSTE Code产品号批准日期申请人
021999 006 NDA INVEGA PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2008/08/26 JANSSEN PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2025 DrugFuture->U.S. FDA Drugs Database