| 药品名称 | STRATTERA | | 申请号 | 021411 | 产品号 | 003 | | 活性成分 | ATOMOXETINE HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 18MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2002/11/26 | 申请机构 | ELI LILLY AND CO
| | 化学类型 | New molecular entity (NME) | 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-562 | 2011/05/07 | | M-66 | 2010/09/28 | | M-78 | 2011/07/23 | | NCE | 2007/11/26 | | PED | 2008/05/26 |
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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 | | 021411 | 047 | AP | Letter | 2015/04/20 | 下载 | | 021411 | 047 | AP | Label | 2015/04/21 | 下载 | | 021411 | 046 | AP | Letter | 2015/05/28 | 下载 | | 021411 | 046 | AP | Label | 2015/05/29 | 下载 | | 021411 | 045 | AP | Label | 2013/12/05 | 下载 | | 021411 | 045 | AP | Letter | 2013/12/09 | 下载 | | 021411 | 044 | AP | Label | 2014/02/21 | 下载 | | 021411 | 044 | AP | Letter | 2014/02/21 | 下载 | | 021411 | 042 | AP | Letter | 2013/08/06 | 下载 | | 021411 | 042 | AP | Label | 2013/08/05 | 下载 | | 021411 | 040 | AP | Label | 2013/08/05 | 下载 | | 021411 | 040 | AP | Letter | 2013/08/06 | 下载 | | 021411 | 039 | AP | Letter | 2012/06/18 | 下载 | | 021411 | 039 | AP | Label | 2012/06/18 | 下载 | | 021411 | 036 | AP | Medication Guide | 2012/08/17 | 下载 | | 021411 | 036 | AP | Letter | 2012/08/20 | 下载 | | 021411 | 036 | AP | Label | 2012/09/12 | 下载 | | 021411 | 035 | AP | Label | 2011/03/07 | 下载 | | 021411 | 035 | AP | Letter | 2011/03/10 | 下载 | | 021411 | 034 | AP | Letter | 2012/07/09 | 下载 | | 021411 | 034 | AP | Label | 2012/07/10 | 下载 | | 021411 | 032 | AP | Letter | 2010/07/30 | 下载 | | 021411 | 032 | AP | Label | 2010/07/31 | 下载 | | 021411 | 030 | AP | Label | 2009/06/04 | 下载 | | 021411 | 030 | AP | Letter | 2009/06/16 | 下载 | | 021411 | 029 | AP | Letter | 2009/06/16 | 下载 | | 021411 | 029 | AP | Label | 2009/06/04 | 下载 | | 021411 | 026 | AP | Letter | 2008/07/25 | 下载 | | 021411 | 026 | AP | Label | 2008/07/29 | 下载 | | 021411 | 025 | AP | Label | 2008/07/29 | 下载 | | 021411 | 025 | AP | Letter | 2008/07/25 | 下载 | | 021411 | 024 | AP | Letter | 2008/07/25 | 下载 | | 021411 | 024 | AP | Label | 2008/07/29 | 下载 | | 021411 | 021 | AP | Letter | 2007/05/01 | 下载 | | 021411 | 021 | AP | Label | 2007/05/01 | 下载 | | 021411 | 019 | AP | Letter | 2007/10/04 | 下载 | | 021411 | 019 | AP | Label | 2007/10/04 | 下载 | | 021411 | 018 | AP | Label | 2006/10/23 | 下载 | | 021411 | 018 | AP | Letter | 2006/10/23 | 下载 | | 021411 | 015 | AP | Label | 2007/05/01 | 下载 | | 021411 | 015 | AP | Letter | 2007/05/01 | 下载 | | 021411 | 014 | AP | Letter | 2005/11/18 | 下载 | | 021411 | 013 | AP | Label | 2007/05/01 | 下载 | | 021411 | 013 | AP | Letter | 2007/05/01 | 下载 | | 021411 | 012 | AP | Letter | 2007/05/01 | 下载 | | 021411 | 012 | AP | Label | 2007/05/01 | 下载 | | 021411 | 011 | AP | Letter | 2005/02/03 | 下载 | | 021411 | 010 | AP | Letter | 2005/02/17 | 下载 | | 021411 | 008 | AP | Letter | 2005/05/27 | 下载 | | 021411 | 005 | AP | Letter | 2008/05/09 | 下载 | | 021411 | 005 | AP | Summary Review | 2008/07/17 | 下载 | | 021411 | 004 | AP | Letter | 2007/05/01 | 下载 | | 021411 | 004 | AP | Label | 2007/05/01 | 下载 | | 021411 | 002 | AP | Letter | 2005/02/03 | 下载 | | 021411 | 001 | AP | Letter | 2003/01/17 | 下载 | | 021411 | 001 | AP | Label | 2003/01/17 | 下载 | | 021411 | 001 | AP | Review | 2007/07/06 | 下载 | | 021411 | 000 | AP | Review | 2003/03/07 | 下载 | | 021411 | 000 | AP | Letter | 2002/11/26 | 下载 | | 021411 | 000 | AP | Label | 2002/11/26 | 下载 | | 021411 | 000 | AP | Other Important Information from FDA | 2005/09/30 | 下载 | | 021411 | 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 | | 021411 | 047 | AP | 2015/04/17 | Labeling Revision | | 021411 | 046 | AP | 2015/05/26 | Labeling Revision | | 021411 | 045 | AP | 2013/12/04 | Labeling Revision | | 021411 | 044 | AP | 2014/02/20 | Labeling Revision | | 021411 | 043 | AP | 2014/02/21 | Manufacturing Change or Addition | | 021411 | 042 | AP | 2013/08/05 | Labeling Revision | | 021411 | 041 | AP | 2013/05/20 | Manufacturing Change or Addition | | 021411 | 040 | AP | 2013/08/05 | Labeling Revision | | 021411 | 039 | AP | 2012/06/14 | Labeling Revision | | 021411 | 036 | AP | 2012/08/16 | Labeling Revision | | 021411 | 035 | AP | 2011/03/07 | Labeling Revision | | 021411 | 034 | AP | 2012/07/05 | Labeling Revision | | 021411 | 032 | AP | 2010/07/29 | Labeling Revision | | 021411 | 030 | AP | 2009/06/03 | Labeling Revision | | 021411 | 029 | AP | 2009/06/03 | Labeling Revision | | 021411 | 026 | AP | 2008/07/23 | Labeling Revision | | 021411 | 025 | AP | 2008/07/23 | Labeling Revision | | 021411 | 024 | AP | 2008/07/23 | Efficacy Supplement with Clinical Data to Support | | 021411 | 021 | AP | 2007/04/25 | Labeling Revision | | 021411 | 019 | AP | 2007/09/28 | Efficacy Supplement with Clinical Data to Support | | 021411 | 018 | AP | 2006/10/19 | Labeling Revision | | 021411 | 015 | AP | 2007/04/25 | Labeling Revision | | 021411 | 014 | AP | 2005/11/08 | Labeling Revision | | 021411 | 013 | AP | 2007/04/25 | Labeling Revision | | 021411 | 012 | AP | 2007/04/25 | Labeling Revision | | 021411 | 011 | AP | 2005/02/01 | Labeling Revision | | 021411 | 010 | AP | 2005/02/14 | Control Supplement | | 021411 | 008 | AP | 2005/05/26 | Efficacy Supplement with Clinical Data to Support | | 021411 | 005 | AP | 2008/05/07 | New or Modified Indication | | 021411 | 004 | AP | 2007/04/25 | Labeling Revision | | 021411 | 002 | AP | 2005/02/01 | Labeling Revision | | 021411 | 001 | AP | 2003/01/17 | Labeling Revision | | 021411 | 000 | AP | 2002/11/26 | Approval |
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