| 药品名称 | EDECRIN | | 申请号 | 016092 | 产品号 | 001 | | 活性成分 | ETHACRYNIC ACID | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 25MG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | ATON PHARMA INC
| | 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 | | 016092 | 042 | AP | Letter | 2005/02/11 | 下载 | | 016092 | 042 | AP | Label | 2005/02/11 | 下载 | | 016092 | 039 | AP | Letter | 2004/03/02 | 下载 | | 016092 | 037 | AP | Review | 1999/10/19 | 下载 |
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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 | | 016092 | 046 | AP | 2015/03/30 | Manufacturing Change or Addition | | 016092 | 042 | AP | 2005/02/09 | Labeling Revision | | 016092 | 039 | AP | 2004/02/03 | Labeling Revision | | 016092 | 038 | AP | 1998/08/14 | Control Supplement | | 016092 | 037 | AP | 1999/10/19 | Labeling Revision | | 016092 | 036 | AP | 1997/11/03 | Labeling Revision | | 016092 | 035 | AP | 1996/06/24 | Control Supplement | | 016092 | 034 | AP | 1995/03/24 | Labeling Revision | | 016092 | 033 | AP | 1994/09/26 | Manufacturing Change or Addition | | 016092 | 032 | AP | 1991/08/07 | Manufacturing Change or Addition | | 016092 | 031 | AP | 1988/09/06 | Manufacturing Change or Addition | | 016092 | 030 | AP | 1988/08/15 | Control Supplement | | 016092 | 029 | AP | 1986/03/21 | Labeling Revision | | 016092 | 028 | AP | 1986/01/13 | Labeling Revision | | 016092 | 027 | AP | 1984/08/28 | Labeling Revision | | 016092 | 026 | AP | 1983/09/20 | Control Supplement | | 016092 | 025 | AP | 1983/05/19 | Control Supplement | | 016092 | 024 | AP | 1981/06/17 | Package Change | | 016092 | 023 | AP | 1985/05/13 | Practioner Draft Labeling | | 016092 | 022 | AP | 1981/09/04 | Formulation Revision | | 016092 | 021 | AP | 1981/01/16 | Labeling Revision | | 016092 | 020 | AP | 1981/02/19 | Formulation Revision | | 016092 | 019 | AP | 1980/11/14 | Package Change | | 016092 | 018 | AP | 1981/01/22 | Formulation Revision | | 016092 | 017 | AP | 1980/01/25 | Labeling Revision | | 016092 | 016 | AP | 1979/11/29 | Labeling Revision | | 016092 | 015 | AP | 1979/06/21 | Control Supplement | | 016092 | 014 | AP | 1979/03/09 | Control Supplement | | 016092 | 012 | AP | 1978/02/22 | Package Change | | 016092 | 011 | AP | 1977/03/21 | Control Supplement | | 016092 | 010 | AP | 1976/02/09 | Control Supplement | | 016092 | 000 | AP | 1967/01/10 | Approval |
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