| 药品名称 | HIBICLENS | | 申请号 | 017768 | 产品号 | 001 | | 活性成分 | CHLORHEXIDINE GLUCONATE | 市场状态 | 非处方药 | | 剂型或给药途径 | SOLUTION;TOPICAL | 规格 | 4% | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | MOLNLYCKE HEALTH CARE
| | 化学类型 | New active ingredient | 审评分类 | Priority 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 | | 017768 | 042 | AP | Label | 2015/12/15 | 下载 | | 017768 | 041 | AP | Letter | 2014/07/01 | 下载 | | 017768 | 041 | AP | Label | 2014/07/31 | 下载 | | 017768 | 039 | AP | Letter | 2012/05/29 | 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 | | 017768 | 042 | AP | 2015/12/09 | Manufacturing Change or Addition | | 017768 | 041 | AP | 2014/06/30 | Labeling Revision | | 017768 | 039 | AP | 2012/05/24 | Labeling Revision | | 017768 | 033 | AP | 2002/07/02 | Manufacturing Change or Addition | | 017768 | 032 | AP | 2001/12/12 | Manufacturing Change or Addition | | 017768 | 031 | AP | 2000/02/23 | Package Change | | 017768 | 030 | AP | 1999/10/20 | Package Change | | 017768 | 029 | AP | 1998/09/30 | Control Supplement | | 017768 | 028 | AP | 1994/03/30 | Package Change | | 017768 | 027 | AP | 1989/07/14 | Formulation Revision | | 017768 | 026 | AP | 1989/07/18 | Control Supplement | | 017768 | 025 | AP | 1989/08/25 | Labeling Revision | | 017768 | 024 | AP | 1988/05/11 | Manufacturing Change or Addition | | 017768 | 023 | AP | 1988/03/03 | Labeling Revision | | 017768 | 022 | AP | 1987/04/06 | Package Change | | 017768 | 019 | AP | 1985/05/09 | Control Supplement | | 017768 | 017 | AP | 1984/06/18 | Manufacturing Change or Addition | | 017768 | 015 | AP | 1981/07/21 | Control Supplement | | 017768 | 014 | AP | 1981/03/10 | Control Supplement | | 017768 | 013 | AP | 1981/01/16 | Package Change | | 017768 | 012 | AP | 1980/12/29 | Control Supplement | | 017768 | 011 | AP | 1987/05/20 | Labeling Revision | | 017768 | 010 | AP | 1980/07/30 | Formulation Revision | | 017768 | 008 | AP | 1979/07/25 | Package Change | | 017768 | 007 | AP | 1979/12/18 | Formulation Revision | | 017768 | 006 | AP | 1979/12/18 | Manufacturing Change or Addition | | 017768 | 005 | AP | 1981/07/06 | Labeling Revision | | 017768 | 004 | AP | 1978/05/12 | Control Supplement | | 017768 | 003 | AP | 1978/01/06 | Manufacturing Change or Addition | | 017768 | 002 | AP | 1982/03/01 | General Efficacy (MarkIV) | | 017768 | 001 | AP | 1977/05/09 | Control Supplement | | 017768 | 000 | AP | 1976/09/17 | Approval |
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