药品名称 | WELLBUTRIN | 申请号 | 018644 | 产品号 | 001 | 活性成分 | BUPROPION HYDROCHLORIDE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 50MG | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1985/12/30 | 申请机构 | GLAXOSMITHKLINE
| 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug |
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与本品相关的专利信息(来自橙皮书Orange Book) | 专利号 | 专利过期日 | 是否化合物专利 | 是否产品专利 | 专利用途代码 | 专利下载 | 无 | 历史专利信息 | 无 |
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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 | 018644 | 050 | AP | Letter | 2016/04/27 | 下载 | 018644 | 050 | AP | Label | 2016/04/27 | 下载 | 018644 | 049 | AP | Letter | 2014/07/21 | 下载 | 018644 | 049 | AP | Label | 2014/07/22 | 下载 | 018644 | 048 | AP | Letter | 2014/12/17 | 下载 | 018644 | 048 | AP | Label | 2014/12/17 | 下载 | 018644 | 047 | AP | Review | 2014/07/07 | 下载 | 018644 | 047 | AP | Label | 2013/12/24 | 下载 | 018644 | 047 | AP | Letter | 2013/12/26 | 下载 | 018644 | 046 | AP | Review | 2014/07/07 | 下载 | 018644 | 046 | AP | Label | 2013/12/24 | 下载 | 018644 | 046 | AP | Letter | 2013/12/26 | 下载 | 018644 | 045 | AP | Letter | 2013/03/21 | 下载 | 018644 | 045 | AP | Label | 2013/03/26 | 下载 | 018644 | 044 | AP | Letter | 2012/08/03 | 下载 | 018644 | 043 | AP | Label | 2011/07/25 | 下载 | 018644 | 043 | AP | Letter | 2011/07/28 | 下载 | 018644 | 042 | AP | Letter | 2011/05/19 | 下载 | 018644 | 042 | AP | Label | 2011/05/23 | 下载 | 018644 | 041 | AP | Letter | 2010/03/03 | 下载 | 018644 | 041 | AP | Medication Guide | 2010/03/03 | 下载 | 018644 | 040 | AP | Label | 2009/07/06 | 下载 | 018644 | 040 | AP | Letter | 2009/07/07 | 下载 | 018644 | 039 | AP | Letter | 2009/07/07 | 下载 | 018644 | 039 | AP | Label | 2009/07/06 | 下载 | 018644 | 038 | AP | Letter | 2010/05/27 | 下载 | 018644 | 038 | AP | Label | 2010/05/28 | 下载 | 018644 | 036 | AP | Label | 2007/08/03 | 下载 | 018644 | 036 | AP | Letter | 2007/08/07 | 下载 | 018644 | 035 | AP | Letter | 2007/02/02 | 下载 | 018644 | 034 | AP | Review | 2012/06/26 | 下载 | 018644 | 034 | AP | Label | 2006/07/05 | 下载 | 018644 | 034 | AP | Letter | 2006/07/13 | 下载 | 018644 | 033 | AP | Label | 2006/07/05 | 下载 | 018644 | 033 | AP | Letter | 2006/07/13 | 下载 | 018644 | 031 | AP | Letter | 2006/03/03 | 下载 | 018644 | 030 | AP | Letter | 2005/01/13 | 下载 | 018644 | 030 | AP | Label | 2005/01/13 | 下载 | 018644 | 028 | AP | Letter | 2004/06/01 | 下载 | 018644 | 028 | AP | Review | 2007/06/29 | 下载 | 018644 | 026 | AP | Letter | 2002/10/22 | 下载 | 018644 | 025 | AP | Letter | 2002/02/12 | 下载 | 018644 | 024 | AP | Letter | 2002/10/02 | 下载 | 018644 | 023 | AP | Letter | 2002/06/20 | 下载 | 018644 | 022 | AP | Letter | 2002/10/02 | 下载 | 018644 | 013 | AP | Review | 2003/06/17 | 下载 | 018644 | 012 | AP | Review | 2003/06/17 | 下载 | 018644 | 010 | AP | Review | 2003/06/17 | 下载 | 018644 | 000 | AP | Other Important Information from FDA | 2005/07/28 | 下载 | 018644 | 000 | AP | Medication Guide | 2009/12/04 | 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 | 018644 | 050 | AP | 2016/04/25 | Labeling Revision | 018644 | 049 | AP | 2014/07/17 | Labeling Revision | 018644 | 048 | AP | 2014/12/16 | Labeling Revision | 018644 | 047 | AP | 2013/12/23 | Labeling Revision | 018644 | 046 | AP | 2013/12/23 | Labeling Revision | 018644 | 045 | AP | 2013/03/19 | Labeling Revision | 018644 | 044 | AP | 2012/08/02 | Supplement | 018644 | 043 | AP | 2011/07/25 | Labeling Revision | 018644 | 042 | AP | 2011/05/17 | Labeling Revision | 018644 | 041 | AP | 2010/02/26 | Labeling Revision | 018644 | 040 | AP | 2009/07/01 | Labeling Revision | 018644 | 039 | AP | 2009/07/01 | Labeling Revision | 018644 | 038 | AP | 2010/05/25 | Labeling Revision | 018644 | 036 | AP | 2007/08/02 | Labeling Revision | 018644 | 035 | AP | 2007/01/29 | Labeling Revision | 018644 | 034 | AP | 2006/07/03 | Labeling Revision | 018644 | 033 | AP | 2006/07/03 | Labeling Revision | 018644 | 031 | AP | 2006/02/28 | Labeling Revision | 018644 | 030 | AP | 2005/01/12 | Labeling Revision | 018644 | 028 | AP | 2004/05/27 | Labeling Revision | 018644 | 026 | AP | 2002/10/22 | Labeling Revision | 018644 | 025 | AP | 2002/02/13 | Manufacturing Change or Addition | 018644 | 024 | AP | 2002/10/02 | Labeling Revision | 018644 | 023 | AP | 2002/06/20 | Labeling Revision | 018644 | 022 | AP | 2002/06/20 | Labeling Revision | 018644 | 021 | AP | 2000/04/10 | Labeling Revision | 018644 | 020 | AP | 2000/04/10 | Labeling Revision | 018644 | 019 | AP | 2000/04/10 | Labeling Revision | 018644 | 018 | AP | 2000/04/10 | Labeling Revision | 018644 | 017 | AP | 2000/04/10 | Labeling Revision | 018644 | 016 | AP | 2000/04/10 | Labeling Revision | 018644 | 015 | AP | 2000/04/10 | Labeling Revision | 018644 | 014 | AP | 2000/04/10 | Labeling Revision | 018644 | 013 | AP | 1996/10/31 | Control Supplement | 018644 | 012 | AP | 1995/11/27 | Labeling Revision | 018644 | 010 | AP | 1995/11/27 | Labeling Revision | 018644 | 008 | AP | 1991/06/24 | Labeling Revision | 018644 | 007 | AP | 1994/03/23 | Package Change | 018644 | 006 | AP | 1994/03/23 | Control Supplement | 018644 | 005 | AP | 1994/03/23 | Formulation Revision | 018644 | 004 | AP | 1991/06/24 | Package Change | 018644 | 003 | AP | 1989/05/30 | Control Supplement | 018644 | 002 | AP | 1986/02/11 | Labeling Revision | 018644 | 001 | AP | 1986/02/11 | Labeling Revision | 018644 | 000 | AP | 1985/12/30 | Approval |
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