| 药品名称 | VIRAMUNE | | 申请号 | 020933 | 产品号 | 001 | | 活性成分 | NEVIRAPINE | 市场状态 | 处方药 | | 剂型或给药途径 | SUSPENSION;ORAL | 规格 | 50MG/5ML | | 治疗等效代码 | AA | 参比药物 | 是 | | 批准日期 | 1998/09/11 | 申请机构 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC
| | 化学类型 | New dosage form | 审评分类 | |
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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 | | 020933 | 035 | AP | Letter | 2014/01/28 | 下载 | | 020933 | 035 | AP | Label | 2014/01/28 | 下载 | | 020933 | 033 | AP | Letter | 2012/11/13 | 下载 | | 020933 | 033 | AP | Label | 2012/11/15 | 下载 | | 020933 | 033 | AP | Medication Guide | 2012/11/15 | 下载 | | 020933 | 030 | AP | Label | 2011/11/10 | 下载 | | 020933 | 030 | AP | Letter | 2011/11/14 | 下载 | | 020933 | 029 | AP | Letter | 2011/05/10 | 下载 | | 020933 | 028 | AP | Label | 2011/03/28 | 下载 | | 020933 | 028 | AP | Letter | 2011/03/31 | 下载 | | 020933 | 027 | AP | Label | 2011/01/10 | 下载 | | 020933 | 027 | AP | Letter | 2011/01/14 | 下载 | | 020933 | 026 | AP | Label | 2010/07/22 | 下载 | | 020933 | 026 | AP | Letter | 2010/07/23 | 下载 | | 020933 | 022 | AP | Label | 2010/01/20 | 下载 | | 020933 | 022 | AP | Letter | 2010/01/26 | 下载 | | 020933 | 019 | AP | Label | 2007/08/17 | 下载 | | 020933 | 019 | AP | Letter | 2007/08/17 | 下载 | | 020933 | 017 | AP | Label | 2008/06/26 | 下载 | | 020933 | 017 | AP | Letter | 2008/06/30 | 下载 | | 020933 | 015 | AP | Letter | 2007/04/20 | 下载 | | 020933 | 015 | AP | Label | 2007/04/20 | 下载 | | 020933 | 014 | AP | Review | 2007/07/27 | 下载 | | 020933 | 014 | AP | Label | 2005/03/02 | 下载 | | 020933 | 014 | AP | Letter | 2005/03/02 | 下载 | | 020933 | 011 | AP | Letter | 2003/12/23 | 下载 | | 020933 | 011 | AP | Label | 2003/12/29 | 下载 | | 020933 | 010 | AP | Letter | 2004/06/30 | 下载 | | 020933 | 010 | AP | Label | 2003/08/06 | 下载 | | 020933 | 007 | AP | Letter | 2002/03/27 | 下载 | | 020933 | 007 | AP | Review | 2005/04/27 | 下载 | | 020933 | 006 | AP | Label | 2003/04/04 | 下载 | | 020933 | 006 | AP | Letter | 2004/06/30 | 下载 | | 020933 | 000 | AP | Letter | 2004/06/30 | 下载 | | 020933 | 000 | AP | Label | 2004/06/30 | 下载 | | 020933 | 000 | AP | Review | 2004/02/09 | 下载 | | 020933 | 000 | AP | Medication Guide | 2007/02/22 | 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 | | 020933 | 037 | AP | 2015/02/03 | Manufacturing Change or Addition | | 020933 | 035 | AP | 2014/01/27 | Labeling Revision | | 020933 | 034 | AP | 2013/02/08 | Manufacturing Change or Addition | | 020933 | 033 | AP | 2012/11/09 | Labeling Revision | | 020933 | 030 | AP | 2011/11/09 | Labeling Revision | | 020933 | 029 | AP | 2011/05/06 | Labeling Revision | | 020933 | 028 | AP | 2011/03/25 | Labeling Revision | | 020933 | 027 | AP | 2011/01/07 | Labeling Revision | | 020933 | 026 | AP | 2010/07/20 | Labeling Revision | | 020933 | 022 | AP | 2010/01/13 | Labeling Revision | | 020933 | 019 | AP | 2007/08/16 | Labeling Revision | | 020933 | 017 | AP | 2008/06/24 | Patient Population Altered | | 020933 | 015 | AP | 2007/04/13 | Labeling Revision | | 020933 | 014 | AP | 2005/02/24 | Labeling Revision | | 020933 | 012 | AP | 2004/05/24 | Labeling Revision | | 020933 | 011 | AP | 2003/12/22 | Labeling Revision | | 020933 | 010 | AP | 2003/07/29 | Labeling Revision | | 020933 | 009 | AP | 2002/12/20 | Control Supplement | | 020933 | 007 | AP | 2002/03/27 | Accelerated Approval | | 020933 | 006 | AP | 2002/12/31 | Labeling Revision | | 020933 | 005 | AP | 2001/02/23 | Control Supplement | | 020933 | 004 | AP | 2001/05/17 | Package Change | | 020933 | 003 | AP | 2000/11/06 | Labeling Revision | | 020933 | 002 | AP | 2000/08/10 | Labeling Revision | | 020933 | 001 | AP | 1999/10/25 | Labeling Revision | | 020933 | 000 | AP | 1998/09/11 | Approval |
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