药品名称 | VIDEX | 申请号 | 020154 | 产品号 | 004 | 活性成分 | DIDANOSINE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET, CHEWABLE;ORAL | 规格 | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1991/10/09 | 申请机构 | BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
| 化学类型 | New molecular entity (NME) | 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 | 020154 | 050 | AP | Label | 2006/12/04 | 下载 | 020154 | 050 | AP | Letter | 2006/12/28 | 下载 | 020154 | 049 | AP | Label | 2006/08/21 | 下载 | 020154 | 049 | AP | Letter | 2006/09/18 | 下载 | 020154 | 049 | AP | Review | 2007/11/19 | 下载 | 020154 | 044 | AP | Letter | 2004/01/22 | 下载 | 020154 | 044 | AP | Label | 2004/01/22 | 下载 | 020154 | 042 | AP | Label | 2003/03/06 | 下载 | 020154 | 042 | AP | Letter | 2003/03/10 | 下载 | 020154 | 041 | AP | Letter | 2002/09/25 | 下载 | 020154 | 041 | AP | Label | 2002/09/25 | 下载 | 020154 | 041 | AP | Review | 2005/04/27 | 下载 | 020154 | 040 | AP | Review | 2005/04/27 | 下载 | 020154 | 040 | AP | Letter | 2002/09/25 | 下载 | 020154 | 040 | AP | Label | 2002/09/25 | 下载 | 020154 | 037 | AP | Letter | 2002/04/01 | 下载 | 020154 | 037 | AP | Label | 2002/04/01 | 下载 | 020154 | 036 | AP | Label | 2003/04/21 | 下载 | 020154 | 035 | AP | Label | 2003/04/21 | 下载 | 020154 | 033 | AP | Review | 2005/04/19 | 下载 | 020154 | 032 | AP | Review | 2005/04/19 | 下载 | 020154 | 030 | AP | Review | 2004/08/09 | 下载 | 020154 | 030 | AP | Letter | 1999/10/29 | 下载 | 020154 | 030 | AP | Label | 1999/10/29 | 下载 | 020154 | 029 | AP | Letter | 1999/10/29 | 下载 | 020154 | 029 | AP | Label | 1999/10/29 | 下载 | 020154 | 029 | AP | Review | 2004/08/09 | 下载 | 020154 | 028 | AP | Review | 2005/01/06 | 下载 | 020154 | 020 | AP | Review | 2007/08/06 | 下载 | 020154 | 009 | AP | Review | 2007/08/06 | 下载 | 020154 | 004 | AP | Review | 2007/08/06 | 下载 | 020154 | 000 | AP | Other Important Information from FDA | 2010/08/09 | 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 | 020154 | 050 | AP | 2006/11/29 | Labeling Revision | 020154 | 049 | AP | 2006/08/18 | Labeling Revision | 020154 | 044 | AP | 2004/01/21 | Labeling Revision | 020154 | 042 | AP | 2003/03/04 | Labeling Revision | 020154 | 041 | AP | 2002/09/25 | Labeling Revision | 020154 | 040 | AP | 2002/09/25 | Labeling Revision | 020154 | 039 | AP | 2002/08/23 | Control Supplement | 020154 | 037 | AP | 2002/04/01 | Efficacy Supplement with Clinical Data to Support | 020154 | 036 | AP | 2001/11/16 | Labeling Revision | 020154 | 035 | AP | 2001/09/10 | Labeling Revision | 020154 | 034 | AP | 2001/07/27 | Labeling Revision | 020154 | 033 | AP | 2000/07/24 | Efficacy Supplement with Clinical Data to Support | 020154 | 032 | AP | 2000/07/24 | Labeling Revision | 020154 | 031 | AP | 2000/07/03 | Labeling Revision | 020154 | 030 | AP | 1999/10/28 | Formulation Revision | 020154 | 029 | AP | 1999/10/28 | New Dosage Regimen | 020154 | 028 | AP | 1999/07/01 | New or Modified Indication | 020154 | 027 | AP | 1998/11/25 | Control Supplement | 020154 | 026 | AP | 1998/11/25 | Control Supplement | 020154 | 025 | AP | 1998/06/23 | Control Supplement | 020154 | 024 | AP | 1998/01/05 | Control Supplement | 020154 | 023 | AP | 1998/04/23 | Labeling Revision | 020154 | 022 | AP | 1996/07/31 | Manufacturing Change or Addition | 020154 | 021 | AP | 1996/06/26 | Labeling Revision | 020154 | 020 | AP | 1996/07/17 | New or Modified Indication | 020154 | 019 | AP | 1996/03/13 | Control Supplement | 020154 | 018 | AP | 1995/07/14 | Control Supplement | 020154 | 017 | AP | 1995/06/15 | Labeling Revision | 020154 | 016 | AP | 1996/06/26 | Labeling Revision | 020154 | 015 | AP | 1995/08/21 | Labeling Revision | 020154 | 014 | AP | 1995/08/21 | Labeling Revision | 020154 | 013 | AP | 1994/02/10 | Labeling Revision | 020154 | 012 | AP | 1995/08/21 | Labeling Revision | 020154 | 011 | AP | 1996/02/27 | Formulation Revision | 020154 | 010 | AP | 1994/04/13 | Control Supplement | 020154 | 009 | AP | 1994/08/05 | New or Modified Indication | 020154 | 008 | AP | 1995/08/21 | Labeling Revision | 020154 | 007 | AP | 1994/02/10 | Labeling Revision | 020154 | 006 | AP | 1992/09/25 | New Dosage Regimen | 020154 | 004 | AP | 1993/02/04 | Package Change | 020154 | 001 | AP | 1992/04/01 | Control Supplement | 020154 | 000 | AP | 1991/10/09 | Approval |
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