| 药品名称 | ESIDRIX | | 申请号 | 011793 | 产品号 | 008 | | 活性成分 | HYDROCHLOROTHIAZIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 50MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | NOVARTIS PHARMACEUTICALS CORP
| | 化学类型 | New molecular entity (NME) | 审评分类 | Standard review drug |
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| 与本品相关的专利信息（来自橙皮书Orange Book） | | 专利号 | 专利过期日 | 是否化合物专利 | 是否产品专利 | 专利用途代码 | 专利下载 | | 无 | | 历史专利信息 | | 无 |
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| 与本品相关的市场独占权保护信息 | | 独占权代码 | 失效日期 | | 无 | | 历史市场独占权保护信息 | | 无 |
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| 与药品注册相关的信息 | | 申请号 | 修订号 | 审批结论 | 公开文档类型 | 文档创建时间 | 获取文档 | | 无 |
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| 药品注册审批历史信息 | | 申请号 | 修订号 | 审批结论 | 审批日期 | 审批内容 | | 011793 | 070 | AP | 2002/04/29 | Manufacturing Change or Addition | | 011793 | 069 | AP | 1999/04/28 | Package Change | | 011793 | 068 | AP | 1997/07/21 | Control Supplement | | 011793 | 067 | AP | 1996/06/20 | Control Supplement | | 011793 | 066 | AP | 1996/02/27 | Manufacturing Change or Addition | | 011793 | 065 | AP | 1995/07/31 | Control Supplement | | 011793 | 064 | AP | 1994/12/01 | Labeling Revision | | 011793 | 062 | AP | 1993/03/10 | Labeling Revision | | 011793 | 061 | AP | 1991/06/05 | Labeling Revision | | 011793 | 060 | AP | 1992/07/30 | Labeling Revision | | 011793 | 059 | AP | 1990/11/09 | Formulation Revision | | 011793 | 058 | AP | 1988/09/23 | Labeling Revision | | 011793 | 057 | AP | 1986/10/02 | Labeling Revision | | 011793 | 056 | AP | 1985/03/19 | Control Supplement | | 011793 | 055 | AP | 1982/12/08 | Control Supplement | | 011793 | 054 | AP | 1982/08/23 | Package Change | | 011793 | 053 | AP | 1982/06/04 | Package Change | | 011793 | 051 | AP | 1986/04/10 | Practioner Draft Labeling | | 011793 | 050 | AP | 1981/02/02 | Package Change | | 011793 | 049 | AP | 1980/01/30 | Package Change | | 011793 | 048 | AP | 1980/01/17 | Package Change | | 011793 | 047 | AP | 1979/06/29 | Package Change | | 011793 | 046 | AP | 1979/06/29 | Package Change | | 011793 | 045 | AP | 1979/06/29 | Package Change | | 011793 | 044 | AP | 1978/01/10 | Formulation Revision | | 011793 | 043 | AP | 1977/06/16 | Control Supplement | | 011793 | 042 | AP | 1977/04/12 | Package Change | | 011793 | 041 | AP | 1978/02/22 | Labeling Revision | | 011793 | 040 | AP | 1977/02/09 | Labeling Revision | | 011793 | 039 | AP | 1976/08/31 | Control Supplement | | 011793 | 038 | AP | 1977/02/09 | Labeling Revision | | 011793 | 037 | AP | 1976/08/18 | Formulation Revision | | 011793 | 036 | AP | 1976/05/20 | Formulation Revision | | 011793 | 035 | AP | 1976/03/24 | Manufacturing Change or Addition | | 011793 | 034 | AP | 1975/10/09 | Labeling Revision | | 011793 | 033 | AP | 1976/03/24 | Control Supplement | | 011793 | 032 | AP | 1975/07/02 | Control Supplement | | 011793 | 030 | AP | 1975/04/02 | Package Change | | 011793 | 029 | AP | 1975/04/02 | Package Change | | 011793 | 000 | AP | 1959/02/12 | Approval |
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