药品注册申请号：020125
申请类型：NDA (新药申请)
申请人：PFIZER PHARMS
申请人全名：PFIZER PHARMACEUTICALS 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 ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 1999/12/28 1999/12/28 Discontinued
002 ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 1999/12/28 Discontinued
003 ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 1999/12/28 Discontinued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
2021/02/19 SUPPL-28（补充） Approval Labeling STANDARD
2020/08/20 SUPPL-27（补充） Approval Labeling STANDARD
2020/05/05 SUPPL-25（补充） Approval Labeling STANDARD
2017/04/26 SUPPL-22（补充） Approval Labeling STANDARD
2016/06/06 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
2015/09/11 SUPPL-20（补充） Approval Labeling STANDARD
2015/02/05 SUPPL-19（补充） Approval Labeling STANDARD
2014/05/02 SUPPL-18（补充） Approval Labeling STANDARD
2014/01/17 SUPPL-16（补充） Approval Labeling STANDARD
2013/10/25 SUPPL-17（补充） Approval Labeling STANDARD
2013/09/23 SUPPL-15（补充） Approval Labeling STANDARD
2012/12/19 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
2012/09/21 SUPPL-14（补充） Approval Labeling STANDARD
2012/01/18 SUPPL-12（补充） Approval Labeling UNKNOWN
2011/10/14 SUPPL-11（补充） Approval Labeling UNKNOWN
2011/03/20 SUPPL-10（补充） Approval Labeling UNKNOWN
2009/09/18 SUPPL-7（补充） Approval Labeling STANDARD
2003/10/29 SUPPL-3（补充） Approval Labeling STANDARD
2002/01/28 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1999/12/28 ORIG-1（原始申请） Approval Type 4 - New Combination 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
001 4743450 2007/02/24 PDF格式**本条是由Drugfuture回溯的历史信息**
4743450*PED 2007/08/24 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4743450 2007/02/24 PDF格式**本条是由Drugfuture回溯的历史信息**
4743450*PED 2007/08/24 PDF格式**本条是由Drugfuture回溯的历史信息**
003 4743450 2007/02/24 PDF格式**本条是由Drugfuture回溯的历史信息**
4743450*PED 2007/08/24 PDF格式**本条是由Drugfuture回溯的历史信息**
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:HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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
020125 001 NDA ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 1999/12/28 PFIZER PHARMS
活性成分:HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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
020125 002 NDA ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 1999/12/28 PFIZER PHARMS
活性成分:HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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
020125 003 NDA ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 1999/12/28 PFIZER PHARMS
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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