| 药品名称 | ZEMPLAR | | 申请号 | 020819 | 产品号 | 001 | | 活性成分 | PARICALCITOL | 市场状态 | 处方药 | | 剂型或给药途径 | SOLUTION;INTRAVENOUS | 规格 | 0.005MG/ML (0.005MG/ML) | | 治疗等效代码 | AP | 参比药物 | 是 | | 批准日期 | 1998/04/17 | 申请机构 | ABBVIE INC
| | 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 | | M-31 | 2007/03/31 | | PED | 2007/10/01 |
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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 | | 020819 | 025 | AP | Label | 2011/04/07 | 下载 | | 020819 | 025 | AP | Letter | 2011/04/11 | 下载 | | 020819 | 024 | AP | Letter | 2011/02/04 | 下载 | | 020819 | 021 | AP | Label | 2009/09/17 | 下载 | | 020819 | 021 | AP | Letter | 2009/11/19 | 下载 | | 020819 | 015 | AP | Label | 2005/09/08 | 下载 | | 020819 | 015 | AP | Letter | 2005/09/08 | 下载 | | 020819 | 014 | AP | Label | 2004/04/05 | 下载 | | 020819 | 014 | AP | Letter | 2004/04/07 | 下载 | | 020819 | 011 | AP | Letter | 2003/03/10 | 下载 | | 020819 | 007 | AP | Letter | 2003/03/10 | 下载 | | 020819 | 003 | AP | Letter | 2000/02/02 | 下载 | | 020819 | 003 | AP | Label | 2000/02/02 | 下载 | | 020819 | 000 | AP | Review | 1998/04/17 | 下载 | | 020819 | 000 | AP | Letter | 1998/04/17 | 下载 | | 020819 | 000 | AP | Label | 1998/04/17 | 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 | | 020819 | 031 | AP | 2013/07/22 | Manufacturing Change or Addition | | 020819 | 025 | AP | 2011/04/06 | Labeling Revision | | 020819 | 024 | AP | 2011/02/01 | Labeling Revision | | 020819 | 021 | AP | 2009/08/20 | Labeling Revision | | 020819 | 015 | AP | 2005/09/02 | Labeling Revision | | 020819 | 014 | AP | 2004/03/31 | Patient Population Altered | | 020819 | 012 | AP | 2002/12/06 | Control Supplement | | 020819 | 011 | AP | 2003/02/24 | Labeling Revision | | 020819 | 010 | AP | 2002/01/25 | Manufacturing Change or Addition | | 020819 | 009 | AP | 2002/01/08 | Expiration Date Change | | 020819 | 007 | AP | 2003/02/24 | Labeling Revision | | 020819 | 006 | AP | 2000/02/01 | Formulation Revision | | 020819 | 005 | AP | 1999/10/18 | Control Supplement | | 020819 | 004 | AP | 2000/09/13 | Labeling Revision | | 020819 | 003 | AP | 2000/02/02 | Efficacy Supplement with Clinical Data to Support | | 020819 | 000 | AP | 1998/04/17 | Approval |
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