| 药品名称 | VIRACEPT | | 申请号 | 020778 | 产品号 | 001 | | 活性成分 | NELFINAVIR MESYLATE | 市场状态 | 停止上市 | | 剂型或给药途径 | POWDER;ORAL | 规格 | EQ 50MG BASE/SCOOPFUL | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1997/03/14 | 申请机构 | AGOURON PHARMACEUTICALS INC
| | 化学类型 | New dosage form | 审评分类 | Priority 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 | | 020778 | 041 | AP | Letter | 2016/09/20 | 下载 | | 020778 | 041 | AP | Label | 2016/09/20 | 下载 | | 020778 | 040 | AP | Letter | 2015/03/31 | 下载 | | 020778 | 040 | AP | Label | 2015/04/07 | 下载 | | 020778 | 038 | AP | Letter | 2013/05/31 | 下载 | | 020778 | 038 | AP | Label | 2013/06/04 | 下载 | | 020778 | 037 | AP | Label | 2012/02/24 | 下载 | | 020778 | 037 | AP | Letter | 2012/02/27 | 下载 | | 020778 | 036 | AP | Label | 2012/04/09 | 下载 | | 020778 | 036 | AP | Letter | 2012/04/11 | 下载 | | 020778 | 035 | AP | Letter | 2011/02/28 | 下载 | | 020778 | 035 | AP | Label | 2011/03/10 | 下载 | | 020778 | 034 | AP | Letter | 2010/04/28 | 下载 | | 020778 | 034 | AP | Label | 2010/05/03 | 下载 | | 020778 | 033 | AP | Label | 2010/05/03 | 下载 | | 020778 | 033 | AP | Letter | 2010/04/28 | 下载 | | 020778 | 032 | AP | Letter | 2008/11/26 | 下载 | | 020778 | 029 | AP | Letter | 2008/02/14 | 下载 | | 020778 | 029 | AP | Label | 2008/02/14 | 下载 | | 020778 | 027 | AP | Label | 2007/12/03 | 下载 | | 020778 | 025 | AP | Label | 2006/12/28 | 下载 | | 020778 | 025 | AP | Letter | 2007/01/08 | 下载 | | 020778 | 024 | AP | Label | 2005/09/30 | 下载 | | 020778 | 024 | AP | Letter | 2005/10/20 | 下载 | | 020778 | 023 | AP | Letter | 2004/06/07 | 下载 | | 020778 | 023 | AP | Label | 2004/06/07 | 下载 | | 020778 | 022 | AP | Letter | 2004/03/24 | 下载 | | 020778 | 022 | AP | Label | 2004/04/05 | 下载 | | 020778 | 022 | AP | Review | 2007/08/06 | 下载 | | 020778 | 020 | AP | Label | 2003/08/28 | 下载 | | 020778 | 020 | AP | Letter | 2003/08/29 | 下载 | | 020778 | 018 | AP | Letter | 2003/07/30 | 下载 | | 020778 | 018 | AP | Label | 2003/04/04 | 下载 | | 020778 | 017 | AP | Letter | 2002/02/05 | 下载 | | 020778 | 016 | AP | Letter | 2002/02/05 | 下载 | | 020778 | 015 | AP | Review | 2007/08/06 | 下载 | | 020778 | 014 | AP | Letter | 2001/04/11 | 下载 | | 020778 | 012 | AP | Review | 2007/08/06 | 下载 | | 020778 | 010 | AP | Review | 2007/08/06 | 下载 | | 020778 | 000 | AP | Review | 1997/03/14 | 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 | | 020778 | 041 | AP | 2016/09/15 | Labeling Revision | | 020778 | 040 | AP | 2015/03/27 | Labeling Revision | | 020778 | 038 | AP | 2013/05/28 | Labeling Revision | | 020778 | 037 | AP | 2012/02/17 | Labeling Revision | | 020778 | 036 | AP | 2012/04/06 | Labeling Revision | | 020778 | 035 | AP | 2011/02/25 | Labeling Revision | | 020778 | 034 | AP | 2010/04/26 | Labeling Revision | | 020778 | 033 | AP | 2010/04/26 | Labeling Revision | | 020778 | 032 | AP | 2008/11/25 | Labeling Revision | | 020778 | 029 | AP | 2008/02/13 | Labeling Revision | | 020778 | 027 | AP | 2007/07/31 | Labeling Revision | | 020778 | 025 | AP | 2006/12/22 | Labeling Revision | | 020778 | 024 | AP | 2005/09/28 | Labeling Revision | | 020778 | 023 | AP | 2004/06/04 | Labeling Revision | | 020778 | 022 | AP | 2004/03/19 | Patient Population Altered | | 020778 | 020 | AP | 2003/08/22 | Labeling Revision | | 020778 | 018 | AP | 2002/12/20 | Labeling Revision | | 020778 | 017 | AP | 2002/02/05 | Labeling Revision | | 020778 | 016 | AP | 2002/02/05 | Control Supplement | | 020778 | 015 | AP | 2001/12/21 | Manufacturing Change or Addition | | 020778 | 014 | AP | 2001/04/05 | Labeling Revision | | 020778 | 013 | AP | 2000/03/28 | Labeling Revision | | 020778 | 012 | AP | 2000/05/17 | Accelerated Approval | | 020778 | 011 | AP | 1999/11/24 | New Dosage Regimen | | 020778 | 010 | AP | 1999/05/25 | Labeling Revision | | 020778 | 009 | AP | 1998/10/30 | Expiration Date Change | | 020778 | 007 | AP | 1998/04/24 | Manufacturing Change or Addition | | 020778 | 006 | AP | 1997/09/30 | Labeling Revision | | 020778 | 005 | AP | 1997/12/19 | Manufacturing Change or Addition | | 020778 | 004 | AP | 1997/10/06 | Expiration Date Change | | 020778 | 003 | AP | 1997/07/31 | Labeling Revision | | 020778 | 002 | AP | 1997/06/04 | Control Supplement | | 020778 | 000 | AP | 1997/03/14 | Approval |
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