药品名称 | DEPAKOTE | 申请号 | 018723 | 产品号 | 002 | 活性成分 | DIVALPROEX SODIUM | 市场状态 | 处方药 | 剂型或给药途径 | TABLET, DELAYED RELEASE;ORAL | 规格 | EQ 500MG VALPROIC ACID | 治疗等效代码 | AB | 参比药物 | 是 | 批准日期 | 1983/03/10 | 申请机构 | ABBVIE INC
| 化学类型 | New dosage form | 审评分类 | Standard 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 | 018723 | 056 | AP | Letter | 2016/02/23 | 下载 | 018723 | 056 | AP | Label | 2016/02/23 | 下载 | 018723 | 055 | AP | Letter | 2015/09/25 | 下载 | 018723 | 055 | AP | Label | 2015/10/06 | 下载 | 018723 | 054 | AP | Letter | 2015/03/17 | 下载 | 018723 | 054 | AP | Label | 2015/03/17 | 下载 | 018723 | 053 | AP | Letter | 2014/08/21 | 下载 | 018723 | 053 | AP | Label | 2014/08/22 | 下载 | 018723 | 052 | AP | Label | 2014/06/10 | 下载 | 018723 | 052 | AP | Letter | 2014/06/11 | 下载 | 018723 | 051 | AP | Letter | 2015/01/08 | 下载 | 018723 | 051 | AP | Label | 2015/01/08 | 下载 | 018723 | 050 | AP | Letter | 2014/11/24 | 下载 | 018723 | 050 | AP | Label | 2014/12/03 | 下载 | 018723 | 049 | AP | Label | 2013/07/02 | 下载 | 018723 | 048 | AP | Letter | 2013/09/17 | 下载 | 018723 | 048 | AP | Label | 2013/09/17 | 下载 | 018723 | 047 | AP | Letter | 2013/03/01 | 下载 | 018723 | 047 | AP | Label | 2013/03/04 | 下载 | 018723 | 046 | AP | Label | 2011/10/12 | 下载 | 018723 | 046 | AP | Letter | 2011/10/13 | 下载 | 018723 | 045 | AP | Letter | 2011/10/13 | 下载 | 018723 | 045 | AP | Label | 2011/10/12 | 下载 | 018723 | 043 | AP | Label | 2011/10/12 | 下载 | 018723 | 043 | AP | Letter | 2011/10/13 | 下载 | 018723 | 041 | AP | Letter | 2014/06/23 | 下载 | 018723 | 041 | AP | Label | 2014/06/23 | 下载 | 018723 | 040 | AP | Letter | 2011/10/13 | 下载 | 018723 | 040 | AP | Label | 2011/10/12 | 下载 | 018723 | 039 | AP | Letter | 2009/05/01 | 下载 | 018723 | 039 | AP | Label | 2009/05/12 | 下载 | 018723 | 037 | AP | Label | 2011/10/12 | 下载 | 018723 | 037 | AP | Letter | 2011/10/13 | 下载 | 018723 | 033 | AP | Label | 2006/10/18 | 下载 | 018723 | 033 | AP | Letter | 2006/10/23 | 下载 | 018723 | 032 | AP | Label | 2006/01/13 | 下载 | 018723 | 032 | AP | Letter | 2006/01/20 | 下载 | 018723 | 029 | AP | Letter | 2004/06/02 | 下载 | 018723 | 000 | AP | Other Important Information from FDA | 2008/02/01 | 下载 | 018723 | 000 | AP | Medication Guide | 2013/03/08 | 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 | 018723 | 056 | AP | 2016/02/19 | Labeling Revision | 018723 | 055 | AP | 2015/09/23 | Labeling Revision | 018723 | 054 | AP | 2015/03/13 | Labeling Revision | 018723 | 053 | AP | 2014/08/20 | Labeling Revision | 018723 | 052 | AP | 2014/06/09 | Labeling Revision | 018723 | 051 | AP | 2015/01/07 | Labeling Revision | 018723 | 050 | AP | 2014/11/20 | Labeling Revision | 018723 | 049 | AP | 2013/06/14 | Labeling Revision | 018723 | 048 | AP | 2013/07/31 | Labeling Revision | 018723 | 047 | AP | 2013/02/27 | Labeling Revision | 018723 | 046 | AP | 2011/10/07 | Labeling Revision | 018723 | 045 | AP | 2011/10/07 | Labeling Revision | 018723 | 043 | AP | 2011/10/07 | Labeling Revision | 018723 | 041 | AP | 2014/06/19 | Labeling Revision | 018723 | 040 | AP | 2011/10/07 | Labeling Revision | 018723 | 039 | AP | 2009/04/23 | Labeling Revision | 018723 | 037 | AP | 2011/10/07 | Labeling Revision | 018723 | 033 | AP | 2006/10/13 | Labeling Revision | 018723 | 032 | AP | 2006/01/11 | Labeling Revision | 018723 | 031 | AP | 2002/12/09 | Control Supplement | 018723 | 030 | AP | 2002/11/05 | Control Supplement | 018723 | 029 | AP | 2002/12/12 | Labeling Revision | 018723 | 028 | AP | 2000/06/19 | Labeling Revision | 018723 | 027 | AP | 1998/09/22 | Control Supplement | 018723 | 026 | AP | 1998/04/02 | Manufacturing Change or Addition | 018723 | 025 | AP | 1998/05/08 | Package Change | 018723 | 024 | AP | 1997/12/24 | Formulation Revision | 018723 | 022 | AP | 1996/12/02 | Control Supplement | 018723 | 020 | AP | 1996/06/20 | New or Modified Indication | 018723 | 019 | AP | 1995/03/23 | Control Supplement | 018723 | 017 | AP | 1996/03/18 | New or Modified Indication | 018723 | 015 | AP | 1994/06/22 | Control Supplement | 018723 | 013 | AP | 1994/03/18 | Manufacturing Change or Addition | 018723 | 012 | AP | 1989/08/16 | Manufacturing Change or Addition | 018723 | 011 | AP | 1989/03/21 | Expiration Date Change | 018723 | 009 | AP | 1988/08/17 | Control Supplement | 018723 | 008 | AP | 1986/11/24 | Expiration Date Change | 018723 | 005 | AP | 1985/12/23 | Expiration Date Change | 018723 | 004 | AP | 1986/08/11 | Labeling Revision | 018723 | 003 | AP | 1985/12/06 | Control Supplement | 018723 | 002 | AP | 1986/08/11 | Labeling Revision | 018723 | 001 | AP | 1984/10/26 | Formulation Revision | 018723 | 000 | AP | 1983/03/10 | Approval |
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