药品注册申请号:077873
申请类型:ANDA (仿制药申请)
申请人:AUROBINDO PHARMA USA
申请人全名:AUROBINDO PHARMA USA 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 HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 12.5MG BASE No No AB 2007/06/29 2007/06/29 Prescription
002 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE No No AB 2007/06/29 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
2021/05/04 SUPPL-25(补充) Approval Labeling STANDARD
2021/05/04 SUPPL-23(补充) Approval Labeling STANDARD
2015/07/15 SUPPL-21(补充) Approval Labeling STANDARD
2013/12/27 SUPPL-20(补充) Approval Labeling STANDARD
2011/12/27 SUPPL-19(补充) Approval Labeling
2011/07/27 SUPPL-15(补充) Approval Labeling
2011/06/24 SUPPL-17(补充) Approval Labeling
2010/08/18 SUPPL-14(补充) Approval Labeling
2010/07/02 SUPPL-11(补充) Approval Labeling
2009/07/22 SUPPL-5(补充) Approval Labeling
2008/11/17 SUPPL-3(补充) Approval Labeling
2008/03/26 SUPPL-2(补充) Approval Labeling
2007/06/29 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
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 PC 2008/11/10**本条是由Drugfuture回溯的历史信息**
002 PC 2008/11/10**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: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
077873 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 12.5MG BASE Prescription No No AB 2007/06/29 AUROBINDO PHARMA USA
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
213485 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 12.5MG BASE Prescription No No AB 2021/02/16 CSPC OUYI
212645 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 12.5MG BASE Prescription No No AB 2021/08/27 CADILA PHARMS LTD
209748 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 12.5MG BASE Prescription No No AB 2024/01/04 PRINSTON 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
077873 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription No No AB 2007/06/29 AUROBINDO PHARMA USA
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
213485 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription No No AB 2021/02/16 CSPC OUYI
212645 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription No No AB 2021/08/27 CADILA PHARMS LTD
209748 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription No No AB 2024/01/04 PRINSTON INC
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