药品注册申请号：203854
申请类型：ANDA (仿制药申请)
申请人：PRINSTON INC
申请人全名：PRINSTON PHARMACEUTICAL 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 PAROXETINE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE No No AB 2014/10/31 2014/10/31 Prescription
002 PAROXETINE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE No No AB 2014/10/31 Prescription
003 PAROXETINE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE No No AB 2014/10/31 Prescription
004 PAROXETINE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE No No AB 2014/10/31 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
2024/07/15 SUPPL-4（补充） Approval Labeling STANDARD
2024/07/15 SUPPL-3（补充） Approval Labeling STANDARD
2020/04/29 SUPPL-1（补充） Approval Labeling STANDARD
2014/10/31 ORIG-1（原始申请） Approval
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
无
与本品治疗等效的药品
活性成分:PAROXETINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE 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
020031 001 NDA PAXIL PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription Yes No AB 1992/12/29 APOTEX
075356 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2003/07/30 APOTEX
076618 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2005/08/15 CHARTWELL RX
077584 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/03/07 ZYDUS PHARMS USA
078406 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/07/25 AUROBINDO PHARMA
078902 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2008/03/13 MYLAN
076968 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2010/06/21 OXFORD PHARMS
203854 001 ANDA PAROXETINE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2014/10/31 PRINSTON INC
211248 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2021/11/02 YILING
活性成分:PAROXETINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 20MG BASE 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
020031 002 NDA PAXIL PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription Yes No AB 1992/12/29 APOTEX
075356 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2003/07/30 APOTEX
076618 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2005/08/15 CHARTWELL RX
077584 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2007/03/07 ZYDUS PHARMS USA
078406 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2007/07/25 AUROBINDO PHARMA
078902 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2008/03/13 MYLAN
076968 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2010/06/21 OXFORD PHARMS
203854 002 ANDA PAROXETINE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2014/10/31 PRINSTON INC
211248 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2021/11/02 YILING
活性成分:PAROXETINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 30MG BASE 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
020031 003 NDA PAXIL PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription Yes No AB 1992/12/29 APOTEX
075356 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2003/07/30 APOTEX
076618 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2005/08/15 CHARTWELL RX
077584 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2007/03/07 ZYDUS PHARMS USA
078406 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2007/07/25 AUROBINDO PHARMA
078902 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2008/03/13 MYLAN
076968 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2010/06/21 OXFORD PHARMS
203854 003 ANDA PAROXETINE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2014/10/31 PRINSTON INC
211248 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2021/11/02 YILING
活性成分:PAROXETINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 40MG BASE 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
020031 005 NDA PAXIL PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription Yes Yes AB 1992/12/29 APOTEX
075356 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2003/07/30 APOTEX
076618 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2005/08/15 CHARTWELL RX
077584 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2007/03/07 ZYDUS PHARMS USA
078406 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2007/07/25 AUROBINDO PHARMA
078902 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2008/03/13 MYLAN
076968 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2010/06/21 OXFORD PHARMS
203854 004 ANDA PAROXETINE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2014/10/31 PRINSTON INC
211248 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2021/11/02 YILING
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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