药品注册申请号:040807
申请类型:ANDA (仿制药申请)
申请人:IPCA LABS LTD
申请人全名:IPCA LABORATORIES 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 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 12.5MG No No AB 2007/07/20 2007/07/20 Prescription
002 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 25MG No No AB 2007/07/20 Prescription
003 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 50MG No No AB 2007/07/20 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
2020/08/20 SUPPL-16(补充) Approval Labeling STANDARD
2011/10/13 SUPPL-11(补充) Approval Labeling
2009/10/19 SUPPL-3(补充) Approval Labeling
2007/07/20 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 剂型/给药途径:TABLET;ORAL 规格:12.5MG 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
040707 001 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 12.5MG Prescription No No AB 2007/02/27 ACTAVIS ELIZABETH
040807 001 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 12.5MG Prescription No No AB 2007/07/20 IPCA LABS LTD
202556 001 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 12.5MG Prescription No No AB 2012/09/24 ACCORD HLTHCARE
040702 003 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 12.5MG Prescription No No AB 2017/05/10 LEADING
085182 003 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 12.5MG Prescription No No AB 2023/05/02 HERITAGE
083177 003 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 12.5MG Prescription Yes No AB 2024/09/19 IVAX SUB TEVA PHARMS
活性成分:HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:25MG 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
083177 001 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 25MG Prescription Yes No AB Approved Prior to Jan 1, 1982 IVAX SUB TEVA PHARMS
085182 002 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 25MG Prescription No No AB Approved Prior to Jan 1, 1982 HERITAGE
087059 001 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 25MG Prescription No No AB Approved Prior to Jan 1, 1982 OXFORD PHARMS
040412 001 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 25MG Discontinued No No AB 2002/03/29 PRINSTON INC
040702 001 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 25MG Prescription No No AB 2007/03/16 LEADING
040780 001 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 25MG Prescription No No AB 2007/07/20 AUROBINDO PHARMA
040807 002 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 25MG Prescription No No AB 2007/07/20 IPCA LABS LTD
040907 001 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 25MG Prescription No No AB 2008/08/15 UNICHEM
202556 002 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 25MG Prescription No No AB 2012/09/24 ACCORD HLTHCARE
203018 001 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 25MG Prescription No No AB 2014/07/23 SCIEGEN PHARMS INC
活性成分:HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:50MG 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
083177 002 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 50MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 IVAX SUB TEVA PHARMS
085182 001 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 50MG Prescription No No AB Approved Prior to Jan 1, 1982 HERITAGE
087068 001 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 50MG Prescription No No AB Approved Prior to Jan 1, 1982 OXFORD PHARMS
040412 002 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 50MG Discontinued No No AB 2002/03/29 PRINSTON INC
040702 002 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 50MG Prescription No No AB 2007/03/16 LEADING
040780 002 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 50MG Prescription No No AB 2007/07/20 AUROBINDO PHARMA
040807 003 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 50MG Prescription No No AB 2007/07/20 IPCA LABS LTD
040907 002 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 50MG Prescription No No AB 2008/08/15 UNICHEM
202556 003 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 50MG Prescription No No AB 2012/09/24 ACCORD HLTHCARE
203018 002 ANDA HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 50MG Prescription No No AB 2014/07/23 SCIEGEN PHARMS INC
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药品NDC数据与药品包装、标签说明书
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