| 药品名称 | EMEND | | 申请号 | 022023 | 产品号 | 001 | | 活性成分 | FOSAPREPITANT DIMEGLUMINE | 市场状态 | 停止上市 | | 剂型或给药途径 | POWDER;INTRAVENOUS | 规格 | EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2008/01/25 | 申请机构 | MERCK AND CO INC
| | 化学类型 | New active ingredient | 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 | | 022023 | 011 | AP | Label | 2014/08/13 | 下载 | | 022023 | 011 | AP | Letter | 2014/08/14 | 下载 | | 022023 | 010 | AP | Letter | 2013/03/29 | 下载 | | 022023 | 010 | AP | Label | 2013/04/01 | 下载 | | 022023 | 009 | AP | Label | 2012/07/10 | 下载 | | 022023 | 009 | AP | Letter | 2012/07/11 | 下载 | | 022023 | 007 | AP | Letter | 2013/03/22 | 下载 | | 022023 | 007 | AP | Label | 2013/03/26 | 下载 | | 022023 | 006 | AP | Label | 2016/02/02 | 下载 | | 022023 | 006 | AP | Letter | 2016/02/03 | 下载 | | 022023 | 005 | AP | Letter | 2010/03/25 | 下载 | | 022023 | 005 | AP | Label | 2010/03/26 | 下载 | | 022023 | 004 | AP | Label | 2010/11/17 | 下载 | | 022023 | 004 | AP | Letter | 2010/11/18 | 下载 | | 022023 | 004 | AP | Review | 2014/01/17 | 下载 | | 022023 | 003 | AP | Label | 2010/03/26 | 下载 | | 022023 | 003 | AP | Letter | 2010/03/25 | 下载 | | 022023 | 002 | AP | Letter | 2010/03/25 | 下载 | | 022023 | 002 | AP | Label | 2010/03/26 | 下载 | | 022023 | 000 | AP | Letter | 2008/01/29 | 下载 | | 022023 | 000 | AP | Label | 2008/01/30 | 下载 | | 022023 | 000 | AP | Review | 2009/04/22 | 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 | | 022023 | 012 | AP | 2015/01/12 | Manufacturing Change or Addition | | 022023 | 011 | AP | 2014/08/12 | Labeling Revision | | 022023 | 010 | AP | 2013/03/27 | Labeling Revision | | 022023 | 009 | AP | 2012/07/06 | Labeling Revision | | 022023 | 007 | AP | 2013/03/20 | Labeling Revision | | 022023 | 006 | AP | 2016/02/01 | Efficacy Supplement with Clinical Data to Support | | 022023 | 005 | AP | 2010/03/23 | Labeling Revision | | 022023 | 004 | AP | 2010/11/12 | New Dosage Regimen | | 022023 | 003 | AP | 2010/03/23 | Labeling Revision | | 022023 | 002 | AP | 2010/03/23 | Labeling Revision | | 022023 | 000 | AP | 2008/01/25 | Approval |
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