| 药品名称 | SIMPONI | | 申请号 | 125289 | 产品号 | 001 | | 活性成分 | GOLIMUMAB | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE; INJECTION | 规格 | 50MG | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | | 申请机构 | CENTOCOR ORTHO BIOTECH INC | | 化学类型 | | 审评分类 | |
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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 | | 125289 | 127 | AP | Letter | 2016/01/11 | 下载 | | 125289 | 127 | AP | Label | 2016/01/12 | 下载 | | 125289 | 124 | AP | Letter | 2015/06/18 | 下载 | | 125289 | 124 | AP | Label | 2015/06/19 | 下载 | | 125289 | 121 | AP | Letter | 2014/12/23 | 下载 | | 125289 | 105 | AP | Letter | 2014/01/27 | 下载 | | 125289 | 105 | AP | Label | 2014/01/28 | 下载 | | 125289 | 103 | AP | Review | 2014/08/01 | 下载 | | 125289 | 103 | AP | Label | 2013/12/30 | 下载 | | 125289 | 103 | AP | Letter | 2013/12/31 | 下载 | | 125289 | 094 | AP | Letter | 2013/11/14 | 下载 | | 125289 | 094 | AP | Label | 2013/11/15 | 下载 | | 125289 | 086 | AP | Label | 2013/05/06 | 下载 | | 125289 | 086 | AP | Letter | 2013/05/08 | 下载 | | 125289 | 084 | AP | Letter | 2013/04/30 | 下载 | | 125289 | 084 | AP | Label | 2013/04/30 | 下载 | | 125289 | 079 | AP | Letter | 2013/05/16 | 下载 | | 125289 | 079 | AP | Label | 2013/05/21 | 下载 | | 125289 | 078 | AP | Label | 2013/05/21 | 下载 | | 125289 | 078 | AP | Letter | 2013/05/16 | 下载 | | 125289 | 077 | AP | Letter | 2013/05/16 | 下载 | | 125289 | 077 | AP | Label | 2013/05/21 | 下载 | | 125289 | 070 | AP | Letter | 2012/11/26 | 下载 | | 125289 | 070 | AP | Label | 2012/11/28 | 下载 | | 125289 | 064 | AP | Label | 2012/03/15 | 下载 | | 125289 | 064 | AP | Letter | 2012/01/03 | 下载 | | 125289 | 053 | AP | Letter | 2011/09/13 | 下载 | | 125289 | 033 | AP | Letter | 2010/10/19 | 下载 | | 125289 | 025 | AP | Letter | 2010/08/03 | 下载 | | 125289 | 025 | AP | Label | 2010/08/10 | 下载 | | 125289 | 025 | AP | Medication Guide | 2010/08/10 | 下载 | | 125289 | 006 | AP | Letter | 2009/11/25 | 下载 | | 125289 | 006 | AP | Label | 2009/12/11 | 下载 | | 125289 | 0038 | AP | Label | 2012/01/11 | 下载 | | 125289 | 0038 | AP | Letter | 2012/01/24 | 下载 | | 125289 | 0029 | AP | Label | 2011/01/05 | 下载 | | 125289 | 0029 | AP | Letter | 2011/01/06 | 下载 | | 125289 | 0020 | AP | Letter | 2011/03/25 | 下载 | | 125289 | 000 | AP | Other Important Information from FDA | 2011/12/20 | 下载 | | 125289 | 000 | AP | Label | 2009/05/05 | 下载 | | 125289 | 000 | AP | Letter | 2009/05/06 | 下载 | | 125289 | 000 | AP | Review | 2009/06/05 | 下载 | | 125289 | 000 | AP | Summary Review | 2009/06/05 | 下载 | | 125289 | 000 | AP | Medication Guide | 2009/11/20 | 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 | | 125289 | 127 | AP | 2016/01/08 | Labeling Revision | | 125289 | 124 | AP | 2015/06/16 | Labeling Revision | | 125289 | 121 | AP | 2014/12/19 | Labeling Revision | | 125289 | 105 | AP | 2014/01/24 | Labeling Revision | | 125289 | 103 | AP | 2013/12/27 | Labeling Revision | | 125289 | 094 | AP | 2013/11/13 | Labeling Revision | | 125289 | 086 | AP | 2013/05/06 | Labeling Revision | | 125289 | 084 | AP | 2013/04/23 | Labeling Revision | | 125289 | 079 | AP | 2013/05/15 | Efficacy Supplement with Clinical Data to Support | | 125289 | 078 | AP | 2013/05/15 | Efficacy Supplement with Clinical Data to Support | | 125289 | 077 | AP | 2013/05/15 | Efficacy Supplement with Clinical Data to Support | | 125289 | 070 | AP | 2012/11/23 | Labeling Revision | | 125289 | 064 | AP | 2011/12/26 | Supplement | | 125289 | 053 | AP | 2011/09/07 | Supplement | | 125289 | 033 | AP | 2010/09/29 | Supplement | | 125289 | 025 | AP | 2010/07/29 | Supplement | | 125289 | 006 | AP | 2009/11/18 | Labeling Revision | | 125289 | 0038 | AP | 2011/08/17 | Labeling Revision | | 125289 | 0029 | AP | 2010/12/22 | Supplement | | 125289 | 0020 | AP | 2011/03/22 | Supplement | | 125289 | 000 | AP | 2009/04/24 | Approval |
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