| 药品名称 | WELLBUTRIN XL | | 申请号 | 021515 | 产品号 | 002 | | 活性成分 | BUPROPION HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET, EXTENDED RELEASE;ORAL | 规格 | 300MG | | 治疗等效代码 | AB3 | 参比药物 | 是 | | 批准日期 | 2003/08/28 | 申请机构 | VALEANT INTERNATIONAL BARBADOS SRL
| | 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 | | I-497 | 2009/06/12 |
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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 | | 021515 | 034 | AP | Letter | 2016/09/02 | 下载 | | 021515 | 034 | AP | Label | 2016/09/02 | 下载 | | 021515 | 032 | AP | Letter | 2014/07/15 | 下载 | | 021515 | 032 | AP | Label | 2014/07/15 | 下载 | | 021515 | 030 | AP | Label | 2015/01/05 | 下载 | | 021515 | 030 | AP | Letter | 2015/01/07 | 下载 | | 021515 | 029 | AP | Letter | 2015/01/07 | 下载 | | 021515 | 029 | AP | Label | 2015/01/05 | 下载 | | 021515 | 028 | AP | Letter | 2012/08/03 | 下载 | | 021515 | 027 | AP | Medication Guide | 2011/07/27 | 下载 | | 021515 | 027 | AP | Letter | 2011/07/28 | 下载 | | 021515 | 027 | AP | Label | 2011/07/27 | 下载 | | 021515 | 026 | AP | Label | 2011/07/27 | 下载 | | 021515 | 026 | AP | Medication Guide | 2011/07/27 | 下载 | | 021515 | 026 | AP | Letter | 2011/07/28 | 下载 | | 021515 | 025 | AP | Medication Guide | 2010/03/03 | 下载 | | 021515 | 024 | AP | Letter | 2009/07/08 | 下载 | | 021515 | 024 | AP | Label | 2009/07/09 | 下载 | | 021515 | 023 | AP | Label | 2009/07/09 | 下载 | | 021515 | 023 | AP | Letter | 2009/07/08 | 下载 | | 021515 | 022 | AP | Letter | 2010/05/27 | 下载 | | 021515 | 022 | AP | Label | 2010/05/28 | 下载 | | 021515 | 020 | AP | Label | 2007/08/03 | 下载 | | 021515 | 020 | AP | Letter | 2007/08/07 | 下载 | | 021515 | 018 | AP | Letter | 2006/06/14 | 下载 | | 021515 | 018 | AP | Label | 2006/06/14 | 下载 | | 021515 | 014 | AP | Label | 2006/07/05 | 下载 | | 021515 | 014 | AP | Letter | 2006/07/13 | 下载 | | 021515 | 012 | AP | Letter | 2006/03/03 | 下载 | | 021515 | 010 | AP | Label | 2006/06/14 | 下载 | | 021515 | 010 | AP | Letter | 2006/06/14 | 下载 | | 021515 | 009 | AP | Letter | 2005/01/13 | 下载 | | 021515 | 009 | AP | Label | 2005/01/13 | 下载 | | 021515 | 007 | AP | Letter | 2004/06/01 | 下载 | | 021515 | 007 | AP | Review | 2007/06/29 | 下载 | | 021515 | 002 | AP | Letter | 2004/10/29 | 下载 | | 021515 | 000 | AP | Letter | 2003/09/09 | 下载 | | 021515 | 000 | AP | Label | 2003/09/09 | 下载 | | 021515 | 000 | AP | Review | 2005/04/27 | 下载 | | 021515 | 000 | AP | Other Important Information from FDA | 2005/07/28 | 下载 | | 021515 | 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 | | 021515 | 034 | AP | 2016/08/30 | Labeling Revision | | 021515 | 033 | AP | 2016/05/24 | Manufacturing Change or Addition | | 021515 | 032 | AP | 2014/07/11 | Labeling Revision | | 021515 | 031 | AP | 2014/11/21 | Manufacturing Change or Addition | | 021515 | 030 | AP | 2014/12/30 | Labeling Revision | | 021515 | 029 | AP | 2014/12/30 | Labeling Revision | | 021515 | 028 | AP | 2012/08/02 | Supplement | | 021515 | 027 | AP | 2011/07/26 | Labeling Revision | | 021515 | 026 | AP | 2011/07/26 | Labeling Revision | | 021515 | 025 | AP | 2010/02/26 | Labeling Revision | | 021515 | 024 | AP | 2009/07/01 | Labeling Revision | | 021515 | 023 | AP | 2009/07/01 | Labeling Revision | | 021515 | 022 | AP | 2010/05/25 | Labeling Revision | | 021515 | 020 | AP | 2007/08/02 | Labeling Revision | | 021515 | 018 | AP | 2006/06/12 | Labeling Revision | | 021515 | 014 | AP | 2006/07/03 | Labeling Revision | | 021515 | 012 | AP | 2006/02/28 | Labeling Revision | | 021515 | 010 | AP | 2006/06/12 | New or Modified Indication | | 021515 | 009 | AP | 2005/01/12 | Labeling Revision | | 021515 | 007 | AP | 2004/05/27 | Labeling Revision | | 021515 | 002 | AP | 2004/10/28 | Labeling Revision | | 021515 | 000 | AP | 2003/08/29 | Approval |
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