药品注册申请号:204134
申请类型:ANDA (仿制药申请)
申请人:LUPIN LTD
申请人全名:LUPIN 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 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 12.5MG BASE No No AB 2017/01/20 2017/01/20 Prescription
002 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE No No AB 2017/01/20 Prescription
003 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE No No AB 2017/01/20 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2017/01/20 ORIG 1 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
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:PAROXETINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 12.5MG 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
020936 001 NDA PAXIL CR PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 12.5MG BASE Prescription Yes No AB 1999/02/16 APOTEX TECHNOLOGIES
077873 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 12.5MG BASE Prescription No No AB 2007/06/29 MYLAN
204744 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 12.5MG BASE Prescription No No AB 2016/06/10 LANNETT CO INC
204134 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 12.5MG BASE Prescription No No AB 2017/01/20 LUPIN LTD
209293 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 12.5MG BASE Prescription No No AB 2018/06/12 SCIECURE PHARMA INC
活性成分:PAROXETINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 25MG 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
020936 002 NDA PAXIL CR PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription Yes No AB 1999/02/16 APOTEX TECHNOLOGIES
077873 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription No No AB 2007/06/29 MYLAN
204744 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription No No AB 2016/06/10 LANNETT CO INC
204134 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription No No AB 2017/01/20 LUPIN LTD
209293 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription No No AB 2018/06/12 SCIECURE PHARMA INC
活性成分:PAROXETINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 37.5MG 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
020936 003 NDA PAXIL CR PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription Yes Yes AB 2000/12/06 APOTEX TECHNOLOGIES
091427 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2011/04/14 MYLAN
204744 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2016/06/10 LANNETT CO INC
204134 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2017/01/20 LUPIN LTD
209293 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2018/06/12 SCIECURE PHARMA INC
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