| 药品名称 | ZERIT | | 申请号 | 020412 | 产品号 | 005 | | 活性成分 | STAVUDINE | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 40MG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 1994/06/24 | 申请机构 | BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
| | 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 | | 020412 | 038 | AP | Letter | 2011/11/22 | 下载 | | 020412 | 038 | AP | Medication Guide | 2011/11/22 | 下载 | | 020412 | 038 | AP | Label | 2011/11/22 | 下载 | | 020412 | 037 | AP | Letter | 2011/05/16 | 下载 | | 020412 | 036 | AP | Medication Guide | 2010/12/23 | 下载 | | 020412 | 036 | AP | Label | 2010/12/23 | 下载 | | 020412 | 036 | AP | Letter | 2010/12/28 | 下载 | | 020412 | 034 | AP | Label | 2009/07/09 | 下载 | | 020412 | 034 | AP | Letter | 2009/07/15 | 下载 | | 020412 | 033 | AP | Letter | 2009/02/18 | 下载 | | 020412 | 033 | AP | Label | 2009/02/20 | 下载 | | 020412 | 032 | AP | Letter | 2008/12/18 | 下载 | | 020412 | 032 | AP | Label | 2009/01/02 | 下载 | | 020412 | 030 | AP | Label | 2008/04/23 | 下载 | | 020412 | 030 | AP | Letter | 2008/04/16 | 下载 | | 020412 | 029 | AP | Label | 2008/04/23 | 下载 | | 020412 | 029 | AP | Letter | 2008/04/16 | 下载 | | 020412 | 027 | AP | Letter | 2007/04/25 | 下载 | | 020412 | 027 | AP | Letter | 2007/06/14 | 下载 | | 020412 | 024 | AP | Label | 2007/02/05 | 下载 | | 020412 | 023 | AP | Letter | 2004/06/07 | 下载 | | 020412 | 023 | AP | Label | 2004/06/07 | 下载 | | 020412 | 018 | AP | Letter | 2002/02/20 | 下载 | | 020412 | 017 | AP | Letter | 2002/02/20 | 下载 | | 020412 | 016 | AP | Letter | 2002/03/29 | 下载 | | 020412 | 016 | AP | Label | 2002/03/29 | 下载 | | 020412 | 015 | AP | Label | 2003/04/22 | 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 | | 020412 | 039 | AP | 2015/07/14 | Manufacturing Change or Addition | | 020412 | 038 | AP | 2011/11/18 | Labeling Revision | | 020412 | 037 | AP | 2011/05/11 | Labeling Revision | | 020412 | 036 | AP | 2010/12/10 | Labeling Revision | | 020412 | 034 | AP | 2009/07/08 | Labeling Revision | | 020412 | 033 | AP | 2009/02/13 | Labeling Revision | | 020412 | 032 | AP | 2008/12/11 | Labeling Revision | | 020412 | 030 | AP | 2008/04/14 | Labeling Revision | | 020412 | 029 | AP | 2008/04/14 | Labeling Revision | | 020412 | 027 | AP | 2007/04/20 | Labeling Revision | | 020412 | 027 | AP | 2007/06/06 | Labeling Revision | | 020412 | 027 | AP | 2007/06/13 | Labeling Revision | | 020412 | 027 | AP | 2007/06/21 | Labeling Revision | | 020412 | 024 | AP | 2005/12/20 | Labeling Revision | | 020412 | 023 | AP | 2004/06/04 | Labeling Revision | | 020412 | 018 | AP | 2002/02/20 | Labeling Revision | | 020412 | 017 | AP | 2002/02/20 | Labeling Revision | | 020412 | 016 | AP | 2002/03/29 | Efficacy Supplement with Clinical Data to Support | | 020412 | 015 | AP | 2001/10/16 | Labeling Revision | | 020412 | 014 | AP | 2001/04/17 | Control Supplement | | 020412 | 013 | AP | 2000/09/27 | Labeling Revision | | 020412 | 012 | AP | 1999/06/10 | Manufacturing Change or Addition | | 020412 | 011 | AP | 1998/09/16 | Labeling Revision | | 020412 | 010 | AP | 1999/07/01 | New or Modified Indication | | 020412 | 009 | AP | 1998/08/19 | Control Supplement | | 020412 | 008 | AP | 1998/01/16 | Manufacturing Change or Addition | | 020412 | 007 | AP | 1998/02/03 | Control Supplement | | 020412 | 006 | AP | 1997/09/26 | Manufacturing Change or Addition | | 020412 | 005 | AP | 1998/02/04 | Labeling Revision | | 020412 | 004 | AP | 1996/09/06 | Patient Population Altered | | 020412 | 003 | AP | 1996/02/09 | Control Supplement | | 020412 | 002 | AP | 1995/12/21 | New or Modified Indication | | 020412 | 001 | AP | 1994/08/02 | Control Supplement | | 020412 | 000 | AP | 1994/06/24 | Approval |
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