| 药品名称 | INVANZ | | 申请号 | 021337 | 产品号 | 001 | | 活性成分 | ERTAPENEM SODIUM | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INTRAMUSCULAR, IV (INFUSION) | 规格 | EQ 1GM BASE/VIAL | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2001/11/21 | 申请机构 | MERCK SHARP AND DOHME 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 | | I-476 | 2008/10/14 | | I-515 | 2009/08/10 | | NCE | 2006/11/21 | | NPP | 2008/05/18 | | PED | 2007/05/21 | | PED | 2008/11/18 |
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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 | | 021337 | 042 | AP | Letter | 2014/10/02 | 下载 | | 021337 | 042 | AP | Label | 2014/10/02 | 下载 | | 021337 | 041 | AP | Letter | 2013/07/26 | 下载 | | 021337 | 041 | AP | Label | 2013/07/30 | 下载 | | 021337 | 038 | AP | Letter | 2012/03/05 | 下载 | | 021337 | 038 | AP | Label | 2012/03/07 | 下载 | | 021337 | 037 | AP | Label | 2012/02/22 | 下载 | | 021337 | 034 | AP | Letter | 2010/05/27 | 下载 | | 021337 | 034 | AP | Label | 2010/05/28 | 下载 | | 021337 | 033 | AP | Label | 2009/10/14 | 下载 | | 021337 | 033 | AP | Letter | 2009/11/10 | 下载 | | 021337 | 031 | AP | Letter | 2011/07/25 | 下载 | | 021337 | 031 | AP | Label | 2011/07/25 | 下载 | | 021337 | 030 | AP | Label | 2009/12/15 | 下载 | | 021337 | 030 | AP | Letter | 2010/01/25 | 下载 | | 021337 | 028 | AP | Letter | 2008/03/26 | 下载 | | 021337 | 028 | AP | Label | 2008/03/27 | 下载 | | 021337 | 026 | AP | Letter | 2007/11/19 | 下载 | | 021337 | 021 | AP | Review | 2014/01/16 | 下载 | | 021337 | 021 | AP | Label | 2006/08/11 | 下载 | | 021337 | 021 | AP | Letter | 2006/08/14 | 下载 | | 021337 | 019 | AP | Letter | 2005/10/19 | 下载 | | 021337 | 019 | AP | Label | 2005/10/19 | 下载 | | 021337 | 018 | AP | Letter | 2005/05/20 | 下载 | | 021337 | 018 | AP | Label | 2005/05/20 | 下载 | | 021337 | 017 | AP | Letter | 2005/01/26 | 下载 | | 021337 | 015 | AP | Letter | 2004/09/10 | 下载 | | 021337 | 014 | AP | Letter | 2004/05/26 | 下载 | | 021337 | 013 | AP | Letter | 2004/05/04 | 下载 | | 021337 | 000 | AP | Letter | 2001/11/09 | 下载 | | 021337 | 000 | AP | Label | 2001/11/09 | 下载 | | 021337 | 000 | AP | Review | 2001/11/09 | 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 | | 021337 | 043 | AP | 2015/03/16 | Manufacturing Change or Addition | | 021337 | 042 | AP | 2014/09/30 | Labeling Revision | | 021337 | 041 | AP | 2013/07/24 | Labeling Revision | | 021337 | 040 | AP | 2013/08/05 | Manufacturing Change or Addition | | 021337 | 039 | AP | 2013/01/18 | Manufacturing Change or Addition | | 021337 | 038 | AP | 2012/03/02 | Labeling Revision | | 021337 | 037 | AP | 2012/02/17 | Labeling Revision | | 021337 | 034 | AP | 2010/05/25 | Labeling Revision | | 021337 | 033 | AP | 2009/10/06 | Labeling Revision | | 021337 | 031 | AP | 2011/07/22 | Labeling Revision | | 021337 | 030 | AP | 2009/12/13 | Labeling Revision | | 021337 | 028 | AP | 2008/03/24 | Labeling Revision | | 021337 | 026 | AP | 2007/11/16 | Labeling Revision | | 021337 | 021 | AP | 2006/08/10 | New or Modified Indication | | 021337 | 019 | AP | 2005/10/14 | New or Modified Indication | | 021337 | 018 | AP | 2005/05/18 | New or Modified Indication | | 021337 | 017 | AP | 2005/01/24 | Labeling Revision | | 021337 | 015 | AP | 2004/09/10 | Labeling Revision | | 021337 | 014 | AP | 2004/05/20 | Labeling Revision | | 021337 | 013 | AP | 2004/04/30 | Labeling Revision | | 021337 | 004 | AP | 2002/12/20 | Control Supplement | | 021337 | 003 | AP | 2002/07/09 | Manufacturing Change or Addition | | 021337 | 002 | AP | 2002/05/09 | Control Supplement | | 021337 | 001 | AP | 2002/05/09 | Control Supplement | | 021337 | 000 | AP | 2001/11/21 | Approval |
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