药品名称 | CRIXIVAN | 申请号 | 020685 | 产品号 | 003 | 活性成分 | INDINAVIR SULFATE | 市场状态 | 处方药 | 剂型或给药途径 | CAPSULE;ORAL | 规格 | EQ 200MG BASE | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1996/03/13 | 申请机构 | MERCK SHARP AND DOHME CORP
| 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 | 020685 | 078 | AP | Letter | 2016/09/20 | 下载 | 020685 | 078 | AP | Label | 2016/09/23 | 下载 | 020685 | 077 | AP | Letter | 2015/04/03 | 下载 | 020685 | 077 | AP | Label | 2015/04/07 | 下载 | 020685 | 076 | AP | Label | 2014/07/28 | 下载 | 020685 | 076 | AP | Letter | 2014/07/28 | 下载 | 020685 | 075 | AP | Label | 2012/02/22 | 下载 | 020685 | 075 | AP | Letter | 2012/02/27 | 下载 | 020685 | 073 | AP | Label | 2010/11/19 | 下载 | 020685 | 072 | AP | Letter | 2011/06/17 | 下载 | 020685 | 071 | AP | Letter | 2010/04/28 | 下载 | 020685 | 071 | AP | Label | 2010/05/03 | 下载 | 020685 | 069 | AP | Label | 2009/10/21 | 下载 | 020685 | 069 | AP | Letter | 2009/11/19 | 下载 | 020685 | 068 | AP | Letter | 2008/12/18 | 下载 | 020685 | 068 | AP | Label | 2009/01/02 | 下载 | 020685 | 066 | AP | Label | 2008/06/05 | 下载 | 020685 | 066 | AP | Letter | 2008/04/22 | 下载 | 020685 | 065 | AP | Label | 2008/04/23 | 下载 | 020685 | 065 | AP | Letter | 2008/04/18 | 下载 | 020685 | 064 | AP | Letter | 2007/07/24 | 下载 | 020685 | 064 | AP | Label | 2007/07/24 | 下载 | 020685 | 063 | AP | Label | 2006/12/14 | 下载 | 020685 | 063 | AP | Letter | 2006/12/28 | 下载 | 020685 | 062 | AP | Label | 2006/08/09 | 下载 | 020685 | 062 | AP | Letter | 2006/08/11 | 下载 | 020685 | 061 | AP | Label | 2006/01/13 | 下载 | 020685 | 061 | AP | Letter | 2006/01/20 | 下载 | 020685 | 060 | AP | Letter | 2004/12/29 | 下载 | 020685 | 060 | AP | Label | 2004/12/29 | 下载 | 020685 | 060 | AP | Review | 2007/09/26 | 下载 | 020685 | 058 | AP | Letter | 2004/01/14 | 下载 | 020685 | 058 | AP | Label | 2004/01/15 | 下载 | 020685 | 057 | AP | Letter | 2003/06/22 | 下载 | 020685 | 057 | AP | Label | 2003/06/22 | 下载 | 020685 | 056 | AP | Letter | 2002/06/20 | 下载 | 020685 | 056 | AP | Label | 2002/06/20 | 下载 | 020685 | 055 | AP | Label | 2002/09/19 | 下载 | 020685 | 055 | AP | Letter | 2002/09/19 | 下载 | 020685 | 054 | AP | Review | 2007/09/26 | 下载 | 020685 | 053 | AP | Label | 2002/06/20 | 下载 | 020685 | 053 | AP | Letter | 2002/06/20 | 下载 | 020685 | 052 | AP | Review | 2007/09/26 | 下载 | 020685 | 050 | AP | Label | 2002/06/20 | 下载 | 020685 | 050 | AP | Letter | 2002/01/25 | 下载 | 020685 | 047 | AP | Letter | 2004/05/07 | 下载 | 020685 | 047 | AP | Review | 2007/09/26 | 下载 | 020685 | 047 | AP | Label | 2004/05/07 | 下载 | 020685 | 046 | AP | Letter | 2004/05/07 | 下载 | 020685 | 046 | AP | Review | 2007/09/26 | 下载 | 020685 | 046 | AP | Label | 2004/05/07 | 下载 | 020685 | 044 | AP | Review | 2007/09/26 | 下载 | 020685 | 043 | AP | Review | 2004/05/06 | 下载 | 020685 | 041 | AP | Review | 2003/04/25 | 下载 | 020685 | 041 | AP | Letter | 2001/03/21 | 下载 | 020685 | 022 | AP | Review | 1998/12/17 | 下载 | 020685 | 005 | AP | Review | 1997/02/19 | 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 | 020685 | 078 | AP | 2016/09/15 | Labeling Revision | 020685 | 077 | AP | 2015/03/27 | Labeling Revision | 020685 | 076 | AP | 2014/07/24 | Labeling Revision | 020685 | 075 | AP | 2012/02/17 | Labeling Revision | 020685 | 073 | AP | 2010/11/19 | Labeling Revision | 020685 | 072 | AP | 2011/06/10 | Labeling Revision | 020685 | 071 | AP | 2010/04/26 | Labeling Revision | 020685 | 069 | AP | 2009/10/15 | Labeling Revision | 020685 | 068 | AP | 2008/12/10 | Labeling Revision | 020685 | 066 | AP | 2008/04/17 | Labeling Revision | 020685 | 065 | AP | 2008/04/16 | Labeling Revision | 020685 | 064 | AP | 2007/07/18 | Labeling Revision | 020685 | 063 | AP | 2006/12/08 | Labeling Revision | 020685 | 062 | AP | 2006/08/07 | Labeling Revision | 020685 | 061 | AP | 2006/01/12 | Labeling Revision | 020685 | 060 | AP | 2004/12/23 | Labeling Revision | 020685 | 058 | AP | 2004/01/12 | Labeling Revision | 020685 | 057 | AP | 2003/06/09 | Labeling Revision | 020685 | 056 | AP | 2002/06/20 | Labeling Revision | 020685 | 055 | AP | 2002/09/19 | Labeling Revision | 020685 | 054 | AP | 2001/10/26 | Manufacturing Change or Addition | 020685 | 053 | AP | 2002/01/25 | Labeling Revision | 020685 | 052 | AP | 2001/09/24 | Control Supplement | 020685 | 051 | AP | 2001/07/13 | Control Supplement | 020685 | 050 | AP | 2002/01/25 | Labeling Revision | 020685 | 049 | AP | 2001/06/01 | Manufacturing Change or Addition | 020685 | 048 | AP | 2001/07/10 | Package Change | 020685 | 047 | AP | 2004/05/07 | Labeling Revision | 020685 | 046 | AP | 2004/05/07 | Labeling Revision | 020685 | 045 | AP | 2000/10/23 | Labeling Revision | 020685 | 044 | AP | 2000/04/19 | Formulation Revision | 020685 | 043 | AP | 2000/10/23 | Efficacy Supplement with Clinical Data to Support | 020685 | 042 | AP | 2000/04/11 | Labeling Revision | 020685 | 041 | AP | 2001/03/21 | Labeling Revision | 020685 | 040 | AP | 2000/10/23 | Labeling Revision | 020685 | 039 | AP | 1999/10/25 | Expiration Date Change | 020685 | 038 | AP | 2000/04/11 | Labeling Revision | 020685 | 036 | AP | 1999/06/04 | Labeling Revision | 020685 | 035 | AP | 2000/04/11 | Labeling Revision | 020685 | 034 | AP | 1999/06/04 | Labeling Revision | 020685 | 033 | AP | 1999/03/12 | Package Change | 020685 | 032 | AP | 1999/06/04 | Labeling Revision | 020685 | 031 | AP | 1999/06/04 | Labeling Revision | 020685 | 030 | AP | 2000/10/23 | Labeling Revision | 020685 | 029 | AP | 1999/02/23 | Control Supplement | 020685 | 028 | AP | 1999/06/04 | Labeling Revision | 020685 | 027 | AP | 1999/06/04 | Labeling Revision | 020685 | 026 | AP | 1999/06/04 | Labeling Revision | 020685 | 025 | AP | 1999/06/04 | Labeling Revision | 020685 | 024 | AP | 1998/12/02 | Package Change | 020685 | 023 | AP | 1999/06/04 | Labeling Revision | 020685 | 022 | AP | 1998/12/17 | Formulation Revision | 020685 | 021 | AP | 1998/06/12 | Control Supplement | 020685 | 020 | AP | 1998/01/15 | Control Supplement | 020685 | 019 | AP | 1997/11/18 | Labeling Revision | 020685 | 018 | AP | 1998/02/06 | Labeling Revision | 020685 | 017 | AP | 1998/02/06 | Labeling Revision | 020685 | 016 | AP | 1998/02/06 | Accelerated Approval | 020685 | 015 | AP | 1997/10/01 | Labeling Revision | 020685 | 014 | AP | 1998/01/15 | Control Supplement | 020685 | 013 | AP | 1997/09/26 | Control Supplement | 020685 | 012 | AP | 1997/08/12 | Expiration Date Change | 020685 | 011 | AP | 1899/12/30 | Labeling Revision | 020685 | 011 | AP | 1997/09/26 | Labeling Revision | 020685 | 010 | AP | 1997/11/21 | Labeling Revision | 020685 | 009 | AP | 1899/12/30 | Labeling Revision | 020685 | 009 | AP | 1997/09/26 | Labeling Revision | 020685 | 008 | AP | 1899/12/30 | Labeling Revision | 020685 | 008 | AP | 1997/09/26 | Labeling Revision | 020685 | 007 | AP | 1997/04/16 | Control Supplement | 020685 | 006 | AP | 1997/03/24 | Labeling Revision | 020685 | 005 | AP | 1997/02/19 | Labeling Revision | 020685 | 004 | AP | 1997/04/03 | Control Supplement | 020685 | 003 | AP | 1996/12/05 | Expiration Date Change | 020685 | 002 | AP | 1997/01/17 | Control Supplement | 020685 | 001 | AP | 1996/08/22 | Manufacturing Change or Addition | 020685 | 000 | AP | 1996/03/13 | Approval |
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