| 药品名称 | HECTOROL | | 申请号 | 020862 | 产品号 | 001 | | 活性成分 | DOXERCALCIFEROL | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 2.5MCG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 1999/06/09 | 申请机构 | GENZYME 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-424 | 2007/04/23 |
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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 | | 020862 | 030 | AP | Letter | 2011/02/15 | 下载 | | 020862 | 030 | AP | Label | 2011/03/04 | 下载 | | 020862 | 024 | AP | Letter | 2009/07/17 | 下载 | | 020862 | 024 | AP | Label | 2009/07/23 | 下载 | | 020862 | 023 | AP | Label | 2008/07/14 | 下载 | | 020862 | 023 | AP | Letter | 2008/07/14 | 下载 | | 020862 | 019 | AP | Label | 2006/07/21 | 下载 | | 020862 | 019 | AP | Letter | 2006/07/21 | 下载 | | 020862 | 018 | AP | Letter | 2005/06/29 | 下载 | | 020862 | 018 | AP | Label | 2005/06/29 | 下载 | | 020862 | 016 | AP | Letter | 2004/12/30 | 下载 | | 020862 | 006 | AP | Letter | 2004/04/29 | 下载 | | 020862 | 006 | AP | Label | 2004/05/04 | 下载 | | 020862 | 000 | AP | Letter | 1999/06/09 | 下载 | | 020862 | 000 | AP | Review | 1999/06/09 | 下载 | | 020862 | 000 | AP | Label | 1999/06/09 | 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 | | 020862 | 032 | AP | 2014/01/02 | Manufacturing Change or Addition | | 020862 | 030 | AP | 2011/02/11 | Labeling Revision | | 020862 | 024 | AP | 2009/07/13 | Control Supplement | | 020862 | 023 | AP | 2008/07/10 | Control Supplement | | 020862 | 019 | AP | 2006/07/20 | Labeling Revision | | 020862 | 018 | AP | 2005/06/24 | Labeling Revision | | 020862 | 016 | AP | 2004/12/17 | Labeling Revision | | 020862 | 010 | AP | 2002/11/19 | Manufacturing Change or Addition | | 020862 | 009 | AP | 2002/07/24 | Manufacturing Change or Addition | | 020862 | 008 | AP | 2002/06/17 | Expiration Date Change | | 020862 | 007 | AP | 2002/06/03 | Manufacturing Change or Addition | | 020862 | 006 | AP | 2004/04/23 | New or Modified Indication | | 020862 | 003 | AP | 2001/06/26 | Manufacturing Change or Addition | | 020862 | 002 | AP | 2001/05/30 | Expiration Date Change | | 020862 | 001 | AP | 2001/06/25 | Labeling Revision | | 020862 | 000 | AP | 1999/06/09 | Approval |
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