药品注册申请号:205618
申请类型:ANDA (仿制药申请)
申请人:SUN PHARM
申请人全名:SUN PHARMACEUTICAL INDUSTRIES LTD
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 PALIPERIDONE PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 1.5mg No No AB 2018/04/06 2018/04/06 Prescription
002 PALIPERIDONE PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 3MG No No AB 2018/04/06 Prescription
003 PALIPERIDONE PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 6MG No No AB 2018/04/06 Prescription
004 PALIPERIDONE PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 9MG No No AB 2018/04/06 Prescription
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
2020/10/30 SUPPL-4(补充) Approval Labeling STANDARD
2020/10/30 SUPPL-2(补充) Approval Labeling STANDARD
2018/04/06 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
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
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RLDRSTE Code产品号批准日期申请人
021999 006 NDA INVEGA PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL 1.5MG Prescription 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
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 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
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 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
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 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
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