药品名称 | NORVIR | 申请号 | 020659 | 产品号 | 001 | 活性成分 | RITONAVIR | 市场状态 | 处方药 | 剂型或给药途径 | SOLUTION;ORAL | 规格 | 80MG/ML | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 1996/03/01 | 申请机构 | ABBVIE INC
| 化学类型 | New molecular entity (NME) | 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 | 020659 | 065 | AP | Letter | 2016/09/19 | 下载 | 020659 | 065 | AP | Label | 2016/09/20 | 下载 | 020659 | 062 | AP | Label | 2015/11/12 | 下载 | 020659 | 062 | AP | Letter | 2015/11/17 | 下载 | 020659 | 062 | AP | Other | 2016/03/04 | 下载 | 020659 | 061 | AP | Letter | 2015/04/03 | 下载 | 020659 | 061 | AP | Label | 2015/04/07 | 下载 | 020659 | 060 | AP | Letter | 2015/03/17 | 下载 | 020659 | 060 | AP | Label | 2015/03/19 | 下载 | 020659 | 058 | AP | Letter | 2013/11/08 | 下载 | 020659 | 058 | AP | Label | 2013/11/08 | 下载 | 020659 | 057 | AP | Letter | 2012/11/23 | 下载 | 020659 | 057 | AP | Label | 2012/11/28 | 下载 | 020659 | 056 | AP | Label | 2012/02/22 | 下载 | 020659 | 056 | AP | Letter | 2012/02/27 | 下载 | 020659 | 055 | AP | Letter | 2011/12/08 | 下载 | 020659 | 055 | AP | Label | 2011/12/14 | 下载 | 020659 | 050 | AP | Letter | 2010/05/03 | 下载 | 020659 | 050 | AP | Label | 2010/05/07 | 下载 | 020659 | 047 | AP | Label | 2009/12/02 | 下载 | 020659 | 047 | AP | Letter | 2010/01/20 | 下载 | 020659 | 045 | AP | Label | 2010/02/16 | 下载 | 020659 | 045 | AP | Letter | 2010/02/17 | 下载 | 020659 | 043 | AP | Letter | 2008/10/02 | 下载 | 020659 | 043 | AP | Label | 2009/08/04 | 下载 | 020659 | 042 | AP | Label | 2008/08/29 | 下载 | 020659 | 042 | AP | Letter | 2008/09/03 | 下载 | 020659 | 040 | AP | Label | 2007/08/02 | 下载 | 020659 | 040 | AP | Letter | 2007/08/02 | 下载 | 020659 | 039 | AP | Letter | 2008/05/20 | 下载 | 020659 | 036 | AP | Letter | 2007/05/16 | 下载 | 020659 | 036 | AP | Label | 2007/05/16 | 下载 | 020659 | 034 | AP | Review | 2007/11/19 | 下载 | 020659 | 034 | AP | Label | 2005/10/10 | 下载 | 020659 | 034 | AP | Letter | 2005/10/11 | 下载 | 020659 | 033 | AP | Label | 2005/11/17 | 下载 | 020659 | 033 | AP | Letter | 2005/11/18 | 下载 | 020659 | 033 | AP | Review | 2007/11/19 | 下载 | 020659 | 032 | AP | Letter | 2005/03/30 | 下载 | 020659 | 032 | AP | Label | 2005/03/30 | 下载 | 020659 | 030 | AP | Letter | 2003/09/25 | 下载 | 020659 | 030 | AP | Label | 2003/09/25 | 下载 | 020659 | 027 | AP | Letter | 2002/03/14 | 下载 | 020659 | 027 | AP | Label | 2002/03/14 | 下载 | 020659 | 026 | AP | Letter | 2001/03/06 | 下载 | 020659 | 025 | AP | Label | 2003/04/25 | 下载 | 020659 | 013 | AP | Review | 2005/04/27 | 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 | 020659 | 065 | AP | 2016/09/15 | Labeling Revision | 020659 | 062 | AP | 2015/11/10 | Labeling Revision | 020659 | 061 | AP | 2015/03/27 | Labeling Revision | 020659 | 060 | AP | 2015/03/16 | Labeling Revision | 020659 | 058 | AP | 2013/11/07 | Labeling Revision | 020659 | 057 | AP | 2012/11/20 | Labeling Revision | 020659 | 056 | AP | 2012/02/17 | Labeling Revision | 020659 | 055 | AP | 2011/12/06 | Labeling Revision | 020659 | 050 | AP | 2010/04/27 | Labeling Revision | 020659 | 047 | AP | 2009/11/23 | Labeling Revision | 020659 | 045 | AP | 2010/02/10 | Labeling Revision | 020659 | 043 | AP | 2008/10/01 | Labeling Revision | 020659 | 042 | AP | 2008/08/29 | Labeling Revision | 020659 | 040 | AP | 2007/07/31 | Labeling Revision | 020659 | 039 | AP | 2008/05/16 | Labeling Revision | 020659 | 036 | AP | 2007/05/10 | Labeling Revision | 020659 | 034 | AP | 2005/10/06 | Patient Population Altered | 020659 | 033 | AP | 2005/11/09 | Labeling Revision | 020659 | 032 | AP | 2005/03/28 | Labeling Revision | 020659 | 030 | AP | 2003/09/10 | Labeling Revision | 020659 | 028 | AP | 2002/12/24 | Control Supplement | 020659 | 027 | AP | 2002/03/14 | Labeling Revision | 020659 | 026 | AP | 2001/03/06 | Labeling Revision | 020659 | 025 | AP | 2001/08/21 | Labeling Revision | 020659 | 024 | AP | 2000/09/01 | Manufacturing Change or Addition | 020659 | 023 | AP | 2000/05/08 | Labeling Revision | 020659 | 022 | AP | 1999/10/26 | Labeling Revision | 020659 | 021 | AP | 1999/10/21 | Labeling Revision | 020659 | 020 | AP | 1999/10/28 | Control Supplement | 020659 | 019 | AP | 1999/04/09 | Labeling Revision | 020659 | 018 | AP | 1999/04/12 | Labeling Revision | 020659 | 017 | AP | 1999/02/26 | Control Supplement | 020659 | 016 | AP | 1998/10/30 | Labeling Revision | 020659 | 015 | AP | 1998/09/25 | Manufacturing Change or Addition | 020659 | 014 | AP | 1998/07/24 | Control Supplement | 020659 | 013 | AP | 1999/05/26 | Accelerated Approval | 020659 | 012 | AP | 1998/02/12 | Labeling Revision | 020659 | 011 | AP | 1998/05/01 | Manufacturing Change or Addition | 020659 | 010 | AP | 1998/01/23 | Manufacturing Change or Addition | 020659 | 009 | AP | 1997/10/31 | Labeling Revision | 020659 | 008 | AP | 1997/03/14 | New Dosage Regimen | 020659 | 007 | AP | 1997/05/09 | Manufacturing Change or Addition | 020659 | 006 | AP | 1997/09/17 | Control Supplement | 020659 | 005 | AP | 1997/01/08 | Labeling Revision | 020659 | 004 | AP | 1996/09/24 | Labeling Revision | 020659 | 003 | AP | 1996/10/01 | Control Supplement | 020659 | 001 | AP | 1996/10/01 | Control Supplement | 020659 | 000 | AP | 1996/03/01 | Approval |
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