药品注册申请号:078450
申请类型:ANDA (仿制药申请)
申请人:AUROBINDO PHARMA
申请人全名:AUROBINDO PHARMA 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 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 10MG BASE No No AB 2007/08/24 2007/08/24 Prescription
002 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 20MG BASE No No AB 2007/08/24 Prescription
003 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 25MG;EQ 20MG BASE No Yes AB 2007/08/24 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
2022/05/26 SUPPL-26(补充) Approval Labeling STANDARD
2022/05/26 SUPPL-24(补充) Approval Labeling STANDARD
2022/05/26 SUPPL-21(补充) Approval Labeling STANDARD
2022/05/26 SUPPL-17(补充) Approval Labeling STANDARD
2016/02/16 SUPPL-15(补充) Approval Labeling STANDARD
2015/04/26 SUPPL-13(补充) Approval Labeling STANDARD
2014/11/26 SUPPL-12(补充) Approval Labeling STANDARD
2014/11/26 SUPPL-11(补充) Approval Labeling STANDARD
2014/11/26 SUPPL-10(补充) Approval Labeling STANDARD
2014/11/26 SUPPL-7(补充) Approval Labeling STANDARD
2014/11/26 SUPPL-6(补充) Approval Labeling
2011/11/28 SUPPL-5(补充) Approval Labeling
2011/08/02 SUPPL-4(补充) Approval Labeling
2010/07/30 SUPPL-2(补充) Approval Labeling
2007/08/24 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
与本品治疗等效的药品
活性成分:HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:12.5MG;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
076374 001 ANDA QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 10MG BASE Discontinued No No AB 2004/03/31 CHARTWELL RX
078450 001 ANDA QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 10MG BASE Prescription No No AB 2007/08/24 AUROBINDO PHARMA
201356 001 ANDA QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 10MG BASE Discontinued No No AB 2011/04/20 INVAGEN PHARMS
091524 001 ANDA QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 10MG BASE Prescription No No AB 2013/03/12 APOTEX
活性成分:HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:12.5MG;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
076374 002 ANDA QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 20MG BASE Discontinued No No AB 2004/03/31 CHARTWELL RX
078450 002 ANDA QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 20MG BASE Prescription No No AB 2007/08/24 AUROBINDO PHARMA
201356 002 ANDA QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 20MG BASE Discontinued No No AB 2011/04/20 INVAGEN PHARMS
091524 002 ANDA QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 20MG BASE Prescription No No AB 2013/03/12 APOTEX
活性成分:HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:25MG;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
076374 003 ANDA QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 25MG;EQ 20MG BASE Discontinued No No AB 2004/03/31 CHARTWELL RX
078450 003 ANDA QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 25MG;EQ 20MG BASE Prescription No Yes AB 2007/08/24 AUROBINDO PHARMA
201356 003 ANDA QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 25MG;EQ 20MG BASE Discontinued No No AB 2011/04/20 INVAGEN PHARMS
091524 003 ANDA QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 25MG;EQ 20MG BASE Prescription No No AB 2013/03/12 APOTEX
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