| 药品名称 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | | 申请号 | 019734 | 产品号 | 004 | | 活性成分 | NICARDIPINE HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INTRAVENOUS | 规格 | 40MG/200ML (0.2MG/ML) | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2008/11/07 | 申请机构 | CHIESI USA INC
| | 化学类型 | New dosage form | 审评分类 | Standard review drug |
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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 | | 019734 | 027 | AP | Letter | 2016/08/29 | 下载 | | 019734 | 027 | AP | Label | 2016/08/29 | 下载 | | 019734 | 023 | AP | Label | 2014/07/24 | 下载 | | 019734 | 023 | AP | Letter | 2014/07/24 | 下载 | | 019734 | 017 | AP | Label | 2011/02/07 | 下载 | | 019734 | 017 | AP | Letter | 2011/02/09 | 下载 | | 019734 | 015 | AP | Letter | 2010/01/15 | 下载 | | 019734 | 015 | AP | Label | 2010/01/20 | 下载 | | 019734 | 014 | AP | Letter | 2008/11/13 | 下载 | | 019734 | 013 | AP | Letter | 2008/08/05 | 下载 | | 019734 | 009 | AP | Letter | 2007/07/05 | 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 | | 019734 | 027 | AP | 2016/08/26 | Labeling Revision | | 019734 | 026 | AP | 2015/12/21 | Manufacturing Change or Addition | | 019734 | 025 | AP | 2015/05/21 | Manufacturing Change or Addition | | 019734 | 024 | AP | 2014/12/02 | Manufacturing Change or Addition | | 019734 | 023 | AP | 2014/07/23 | Labeling Revision | | 019734 | 022 | AP | 2014/04/30 | Manufacturing Change or Addition | | 019734 | 021 | AP | 2013/09/27 | Manufacturing Change or Addition | | 019734 | 020 | AP | 2013/05/02 | Manufacturing Change or Addition | | 019734 | 017 | AP | 2011/02/07 | Labeling Revision | | 019734 | 015 | AP | 2010/01/13 | Labeling Revision | | 019734 | 014 | AP | 2008/11/07 | Formulation Revision | | 019734 | 013 | AP | 2008/07/31 | Formulation Revision | | 019734 | 009 | AP | 2007/06/22 | Labeling Revision | | 019734 | 005 | AP | 2002/10/24 | Control Supplement | | 019734 | 004 | AP | 1997/04/29 | Manufacturing Change or Addition | | 019734 | 003 | AP | 1995/04/10 | Control Supplement | | 019734 | 002 | AP | 1995/05/12 | Manufacturing Change or Addition | | 019734 | 001 | AP | 1992/11/20 | Control Supplement | | 019734 | 000 | AP | 1992/01/30 | Approval |
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