药品名称 | WELLBUTRIN SR | 申请号 | 020358 | 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, EXTENDED RELEASE;ORAL | 规格 | 50MG | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1996/10/04 | 申请机构 | GLAXOSMITHKLINE
| 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 | 020358 | 057 | AP | Letter | 2016/04/27 | 下载![](pdf.jpg) | 020358 | 057 | AP | Label | 2016/04/27 | 下载![](pdf.jpg) | 020358 | 056 | AP | Letter | 2014/07/21 | 下载![](pdf.jpg) | 020358 | 056 | AP | Label | 2014/07/22 | 下载![](pdf.jpg) | 020358 | 055 | AP | Letter | 2014/12/17 | 下载![](pdf.jpg) | 020358 | 055 | AP | Label | 2014/12/17 | 下载![](pdf.jpg) | 020358 | 054 | AP | Letter | 2013/12/26 | 下载![](pdf.jpg) | 020358 | 054 | AP | Review | 2014/07/07 | 下载![](pdf.jpg) | 020358 | 054 | AP | Label | 2013/12/24 | 下载![](pdf.jpg) | 020358 | 053 | AP | Letter | 2013/12/26 | 下载![](pdf.jpg) | 020358 | 053 | AP | Label | 2013/12/24 | 下载![](pdf.jpg) | 020358 | 053 | AP | Review | 2014/07/07 | 下载![](pdf.jpg) | 020358 | 052 | AP | Letter | 2013/03/21 | 下载![](pdf.jpg) | 020358 | 052 | AP | Label | 2013/03/26 | 下载![](pdf.jpg) | 020358 | 051 | AP | Letter | 2012/08/03 | 下载![](pdf.jpg) | 020358 | 050 | AP | Label | 2011/07/25 | 下载![](pdf.jpg) | 020358 | 050 | AP | Letter | 2011/07/28 | 下载![](pdf.jpg) | 020358 | 049 | AP | Letter | 2011/05/19 | 下载![](pdf.jpg) | 020358 | 049 | AP | Label | 2011/05/23 | 下载![](pdf.jpg) | 020358 | 048 | AP | Letter | 2010/03/03 | 下载![](pdf.jpg) | 020358 | 048 | AP | Medication Guide | 2010/03/03 | 下载![](pdf.jpg) | 020358 | 047 | AP | Label | 2009/07/06 | 下载![](pdf.jpg) | 020358 | 047 | AP | Letter | 2009/07/07 | 下载![](pdf.jpg) | 020358 | 046 | AP | Letter | 2009/07/07 | 下载![](pdf.jpg) | 020358 | 046 | AP | Label | 2009/07/06 | 下载![](pdf.jpg) | 020358 | 045 | AP | Letter | 2010/05/27 | 下载![](pdf.jpg) | 020358 | 045 | AP | Label | 2010/05/28 | 下载![](pdf.jpg) | 020358 | 043 | AP | Label | 2007/08/03 | 下载![](pdf.jpg) | 020358 | 043 | AP | Letter | 2007/08/07 | 下载![](pdf.jpg) | 020358 | 042 | AP | Label | 2007/02/02 | 下载![](pdf.jpg) | 020358 | 042 | AP | Letter | 2007/02/02 | 下载![](pdf.jpg) | 020358 | 040 | AP | Letter | 2006/07/13 | 下载![](pdf.jpg) | 020358 | 040 | AP | Label | 2006/07/05 | 下载![](pdf.jpg) | 020358 | 040 | AP | Review | 2012/06/26 | 下载![](pdf.jpg) | 020358 | 039 | AP | Label | 2011/05/23 | 下载![](pdf.jpg) | 020358 | 039 | AP | Letter | 2011/05/19 | 下载![](pdf.jpg) | 020358 | 037 | AP | Label | 2006/07/05 | 下载![](pdf.jpg) | 020358 | 037 | AP | Letter | 2006/07/13 | 下载![](pdf.jpg) | 020358 | 035 | AP | Letter | 2006/03/03 | 下载![](pdf.jpg) | 020358 | 034 | AP | Letter | 2005/01/13 | 下载![](pdf.jpg) | 020358 | 034 | AP | Label | 2005/01/13 | 下载![](pdf.jpg) | 020358 | 032 | AP | Letter | 2004/06/01 | 下载![](pdf.jpg) | 020358 | 032 | AP | Review | 2007/06/29 | 下载 | 020358 | 030 | AP | Letter | 2004/04/29 | 下载![](pdf.jpg) | 020358 | 029 | AP | Letter | 2002/10/22 | 下载![](pdf.jpg) | 020358 | 028 | AP | Letter | 2002/07/12 | 下载![](pdf.jpg) | 020358 | 027 | AP | Letter | 2002/06/14 | 下载![](pdf.jpg) | 020358 | 027 | AP | Label | 2002/06/14 | 下载![](pdf.jpg) | 020358 | 027 | AP | Review | 2007/04/09 | 下载![](pdf.jpg) | 020358 | 025 | AP | Review | 2011/12/09 | 下载![](pdf.jpg) | 020358 | 024 | AP | Letter | 2002/10/02 | 下载![](pdf.jpg) | 020358 | 023 | AP | Letter | 2002/06/20 | 下载![](pdf.jpg) | 020358 | 022 | AP | Review | 2011/12/09 | 下载![](pdf.jpg) | 020358 | 021 | AP | Review | 2011/12/09 | 下载![](pdf.jpg) | 020358 | 020 | AP | Review | 2011/12/09 | 下载![](pdf.jpg) | 020358 | 019 | AP | Letter | 2001/06/11 | 下载![](pdf.jpg) | 020358 | 019 | AP | Label | 2001/06/11 | 下载![](pdf.jpg) | 020358 | 019 | AP | Review | 2001/06/11 | 下载![](pdf.jpg) | 020358 | 018 | AP | Letter | 2002/10/02 | 下载![](pdf.jpg) | 020358 | 003 | AP | Review | 1997/12/16 | 下载![](pdf.jpg) | 020358 | 001 | AP | Review | 1997/12/16 | 下载![](pdf.jpg) | 020358 | 000 | AP | Other Important Information from FDA | 2005/07/28 | 下载 | 020358 | 000 | AP | Medication Guide | 2009/12/04 | 下载![](pdf.jpg) |
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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 | 020358 | 057 | AP | 2016/04/25 | Labeling Revision | 020358 | 056 | AP | 2014/07/17 | Labeling Revision | 020358 | 055 | AP | 2014/12/16 | Labeling Revision | 020358 | 054 | AP | 2013/12/23 | Labeling Revision | 020358 | 053 | AP | 2013/12/23 | Labeling Revision | 020358 | 052 | AP | 2013/03/19 | Labeling Revision | 020358 | 051 | AP | 2012/08/02 | Supplement | 020358 | 050 | AP | 2011/07/25 | Labeling Revision | 020358 | 049 | AP | 2011/05/17 | Labeling Revision | 020358 | 048 | AP | 2010/02/26 | Labeling Revision | 020358 | 047 | AP | 2009/07/01 | Labeling Revision | 020358 | 046 | AP | 2009/07/01 | Labeling Revision | 020358 | 045 | AP | 2010/05/25 | Labeling Revision | 020358 | 043 | AP | 2007/08/02 | Labeling Revision | 020358 | 042 | AP | 2007/01/29 | Labeling Revision | 020358 | 040 | AP | 2006/07/03 | Labeling Revision | 020358 | 039 | AP | 2011/05/17 | Labeling Revision | 020358 | 037 | AP | 2006/07/03 | Labeling Revision | 020358 | 035 | AP | 2006/02/28 | Labeling Revision | 020358 | 034 | AP | 2005/01/12 | Labeling Revision | 020358 | 032 | AP | 2004/05/27 | Labeling Revision | 020358 | 030 | AP | 2004/04/26 | Labeling Revision | 020358 | 029 | AP | 2002/10/22 | Labeling Revision | 020358 | 028 | AP | 2002/07/12 | Manufacturing Change or Addition | 020358 | 027 | AP | 2002/06/14 | Manufacturing Change or Addition | 020358 | 026 | AP | 2002/07/12 | Package Change | 020358 | 025 | AP | 2002/02/13 | Manufacturing Change or Addition | 020358 | 024 | AP | 2002/10/02 | Labeling Revision | 020358 | 023 | AP | 2002/06/20 | Labeling Revision | 020358 | 022 | AP | 2000/10/11 | Manufacturing Change or Addition | 020358 | 021 | AP | 2000/10/11 | Control Supplement | 020358 | 020 | AP | 2000/10/11 | Formulation Revision | 020358 | 019 | AP | 2001/06/11 | Efficacy Supplement with Clinical Data to Support | 020358 | 018 | AP | 2002/06/20 | Labeling Revision | 020358 | 017 | AP | 2000/08/04 | Control Supplement | 020358 | 016 | AP | 2000/04/10 | Labeling Revision | 020358 | 015 | AP | 2000/04/10 | Labeling Revision | 020358 | 014 | AP | 2000/04/10 | Labeling Revision | 020358 | 013 | AP | 2000/04/10 | Labeling Revision | 020358 | 012 | AP | 2000/04/10 | Labeling Revision | 020358 | 011 | AP | 1999/04/06 | Manufacturing Change or Addition | 020358 | 010 | AP | 1999/04/06 | Package Change | 020358 | 009 | AP | 1999/04/06 | Expiration Date Change | 020358 | 008 | AP | 2000/04/10 | Labeling Revision | 020358 | 007 | AP | 2000/04/10 | Labeling Revision | 020358 | 006 | AP | 1998/11/30 | Manufacturing Change or Addition | 020358 | 005 | AP | 1998/11/30 | Control Supplement | 020358 | 004 | AP | 1998/11/30 | Package Change | 020358 | 003 | AP | 1997/12/16 | Labeling Revision | 020358 | 002 | AP | 1999/01/26 | Labeling Revision | 020358 | 001 | AP | 1997/12/16 | Labeling Revision | 020358 | 000 | AP | 1996/10/04 | Approval |
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