药品名称 | MEGACE ES | 申请号 | 021778 | 产品号 | 001 | 活性成分 | MEGESTROL ACETATE | 市场状态 | 处方药 | 剂型或给药途径 | SUSPENSION;ORAL | 规格 | 125MG/ML | 治疗等效代码 | AB | 参比药物 | 是 | 批准日期 | 2005/07/05 | 申请机构 | ENDO PHARMACEUTICALS INC
| 化学类型 | New formulation or new manufacturer | 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 | 021778 | 018 | AP | Label | 2014/09/22 | 下载 | 021778 | 018 | AP | Letter | 2014/09/23 | 下载 | 021778 | 016 | AP | Letter | 2013/05/16 | 下载 | 021778 | 016 | AP | Label | 2013/05/21 | 下载 | 021778 | 008 | AP | Letter | 2010/07/28 | 下载 | 021778 | 008 | AP | Label | 2010/07/30 | 下载 | 021778 | 007 | AP | Letter | 2008/08/19 | 下载 | 021778 | 003 | AP | Label | 2007/03/23 | 下载 | 021778 | 003 | AP | Letter | 2007/03/23 | 下载 | 021778 | 002 | AP | Label | 2007/03/23 | 下载 | 021778 | 002 | AP | Letter | 2007/03/23 | 下载 | 021778 | 000 | AP | Review | 2007/07/02 | 下载 | 021778 | 000 | AP | Label | 2005/07/07 | 下载 | 021778 | 000 | AP | Letter | 2005/07/08 | 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 | 021778 | 022 | AP | 2015/11/05 | Manufacturing Change or Addition | 021778 | 020 | AP | 2014/10/16 | Manufacturing Change or Addition | 021778 | 019 | AP | 2014/10/16 | Manufacturing Change or Addition | 021778 | 018 | AP | 2014/09/18 | Labeling Revision | 021778 | 017 | AP | 2014/07/31 | Manufacturing Change or Addition | 021778 | 016 | AP | 2013/05/14 | Labeling Revision | 021778 | 015 | AP | 2014/03/17 | Manufacturing Change or Addition | 021778 | 014 | AP | 2013/06/14 | Manufacturing Change or Addition | 021778 | 013 | AP | 2013/01/25 | Manufacturing Change or Addition | 021778 | 008 | AP | 2010/07/21 | Labeling Revision | 021778 | 007 | AP | 2008/08/12 | Labeling Revision | 021778 | 003 | AP | 2007/03/19 | Manufacturing Change or Addition | 021778 | 002 | AP | 2007/03/19 | Labeling Revision | 021778 | 000 | AP | 2005/07/05 | Approval |
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