药品注册申请号:213612
申请类型:ANDA (仿制药申请)
申请人:EPIC PHARMA LLC
申请人全名:EPIC PHARMA LLC
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 None 2021/08/11 2021/08/11 Discontinued
002 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE No No None 2021/08/11 Discontinued
003 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE No No AB 2022/05/26 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
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
2022/05/26 SUPPL-1(补充) Approval Manufacturing (CMC) UNKNOWN
2021/08/11 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: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
091427 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2011/04/14 AUROBINDO PHARMA USA
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
213485 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2021/02/16 CSPC OUYI
212645 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2021/08/27 CADILA PHARMS LTD
213612 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Discontinued No No AB 2022/05/26 EPIC PHARMA LLC
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药品NDC数据与药品包装、标签说明书
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