| 药品名称 | ZOMETA | | 申请号 | 021223 | 产品号 | 003 | | 活性成分 | ZOLEDRONIC ACID | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;IV (INFUSION) | 规格 | EQ 4MG BASE/100ML | | 治疗等效代码 | AP | 参比药物 | 是 | | 批准日期 | 2011/06/17 | 申请机构 | NOVARTIS PHARMACEUTICALS CORP
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug | | 罕用药/孤儿药 | 是 | | |
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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 | | 021223 | 034 | AP | Label | 2016/03/31 | 下载 | | 021223 | 034 | AP | Letter | 2016/04/04 | 下载 | | 021223 | 032 | AP | Letter | 2015/06/10 | 下载 | | 021223 | 032 | AP | Label | 2015/06/11 | 下载 | | 021223 | 031 | AP | Letter | 2015/01/07 | 下载 | | 021223 | 031 | AP | Label | 2015/01/08 | 下载 | | 021223 | 028 | AP | Letter | 2014/04/08 | 下载 | | 021223 | 028 | AP | Label | 2014/04/08 | 下载 | | 021223 | 027 | AP | Letter | 2013/10/01 | 下载 | | 021223 | 027 | AP | Label | 2013/10/01 | 下载 | | 021223 | 023 | AP | Letter | 2012/11/14 | 下载 | | 021223 | 023 | AP | Label | 2012/11/15 | 下载 | | 021223 | 022 | AP | Letter | 2012/03/16 | 下载 | | 021223 | 022 | AP | Label | 2012/03/16 | 下载 | | 021223 | 018 | AP | Label | 2009/11/17 | 下载 | | 021223 | 018 | AP | Letter | 2010/01/25 | 下载 | | 021223 | 016 | AP | Letter | 2008/03/21 | 下载 | | 021223 | 016 | AP | Label | 2008/03/24 | 下载 | | 021223 | 015 | AP | Letter | 2007/11/08 | 下载 | | 021223 | 014 | AP | Label | 2007/11/07 | 下载 | | 021223 | 014 | AP | Letter | 2007/11/08 | 下载 | | 021223 | 012 | AP | Label | 2006/05/26 | 下载 | | 021223 | 012 | AP | Letter | 2006/05/26 | 下载 | | 021223 | 011 | AP | Letter | 2005/10/14 | 下载 | | 021223 | 011 | AP | Label | 2005/10/14 | 下载 | | 021223 | 010 | AP | Label | 2005/02/03 | 下载 | | 021223 | 010 | AP | Letter | 2005/02/03 | 下载 | | 021223 | 009 | AP | Label | 2005/02/03 | 下载 | | 021223 | 009 | AP | Letter | 2005/02/03 | 下载 | | 021223 | 008 | AP | Letter | 2004/03/28 | 下载 | | 021223 | 008 | AP | Label | 2004/04/05 | 下载 | | 021223 | 006 | AP | Letter | 2004/03/02 | 下载 | | 021223 | 006 | AP | Label | 2004/03/25 | 下载 | | 021223 | 004 | AP | Label | 2003/03/26 | 下载 | | 021223 | 004 | AP | Letter | 2003/03/26 | 下载 | | 021223 | 004 | AP | Review | 2008/08/01 | 下载 | | 021223 | 003 | AP | Letter | 2002/02/22 | 下载 | | 021223 | 003 | AP | Label | 2002/02/22 | 下载 | | 021223 | 003 | AP | Review | 2002/02/22 | 下载 | | 021223 | 000 | AP | Letter | 2001/08/20 | 下载 | | 021223 | 000 | AP | Label | 2001/08/20 | 下载 | | 021223 | 000 | AP | Review | 2001/08/20 | 下载 | | 021223 | 000 | AP | Other Important Information from FDA | 2003/12/12 | 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 | | 021223 | 034 | AP | 2016/03/29 | Labeling Revision | | 021223 | 033 | AP | 2016/04/22 | Manufacturing Change or Addition | | 021223 | 032 | AP | 2015/06/09 | Labeling Revision | | 021223 | 031 | AP | 2015/01/05 | Labeling Revision | | 021223 | 030 | AP | 2014/06/17 | Manufacturing Change or Addition | | 021223 | 028 | AP | 2014/04/07 | Labeling Revision | | 021223 | 027 | AP | 2013/09/27 | Labeling Revision | | 021223 | 025 | AP | 2013/03/06 | Manufacturing Change or Addition | | 021223 | 023 | AP | 2012/11/09 | Labeling Revision | | 021223 | 022 | AP | 2012/03/14 | Labeling Revision | | 021223 | 018 | AP | 2009/11/09 | Labeling Revision | | 021223 | 016 | AP | 2008/03/20 | Patient Population Altered | | 021223 | 015 | AP | 2007/11/02 | Supplement | | 021223 | 014 | AP | 2007/11/02 | Labeling Revision | | 021223 | 012 | AP | 2006/05/25 | Labeling Revision | | 021223 | 011 | AP | 2005/10/11 | Labeling Revision | | 021223 | 010 | AP | 2005/01/31 | Labeling Revision | | 021223 | 009 | AP | 2005/01/31 | Labeling Revision | | 021223 | 008 | AP | 2004/03/24 | Labeling Revision | | 021223 | 006 | AP | 2004/02/27 | Labeling Revision | | 021223 | 004 | AP | 2003/03/07 | Formulation Revision | | 021223 | 003 | AP | 2002/02/22 | Labeling Revision | | 021223 | 002 | AP | 2002/05/13 | Manufacturing Change or Addition | | 021223 | 001 | AP | 2002/02/12 | Manufacturing Change or Addition | | 021223 | 000 | AP | 2001/08/20 | Approval |
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