药品名称 | BOTOX COSMETIC | 申请号 | 103000 | 产品号 | 004 | 活性成分 | OnabotulinumtoxinA | 市场状态 | 处方药 | 剂型或给药途径 | VIAL; SINGLE-USE | 规格 | 50 UNITS/VIAL | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | | 申请机构 | ALLERGAN | 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 | 103000 | 5294 | AP | Letter | 2016/02/05 | 下载![](pdf.jpg) | 103000 | 5292 | AP | Letter | 2015/08/12 | 下载![](pdf.jpg) | 103000 | 5292 | AP | Label | 2015/08/12 | 下载![](pdf.jpg) | 103000 | 5282 | AP | Letter | 2015/04/21 | 下载![](pdf.jpg) | 103000 | 5282 | AP | Label | 2015/04/21 | 下载![](pdf.jpg) | 103000 | 5280 | AP | Letter | 2014/05/08 | 下载![](pdf.jpg) | 103000 | 5260 | AP | Letter | 2013/09/13 | 下载![](pdf.jpg) | 103000 | 5260 | AP | Label | 2013/09/17 | 下载![](pdf.jpg) | 103000 | 5256 | AP | Letter | 2012/07/18 | 下载![](pdf.jpg) | 103000 | 5253 | AP | Letter | 2012/11/14 | 下载![](pdf.jpg) | 103000 | 5253 | AP | Medication Guide | 2012/11/14 | 下载![](pdf.jpg) | 103000 | 5253 | AP | Label | 2012/11/14 | 下载![](pdf.jpg) | 103000 | 5252 | AP | Letter | 2016/01/22 | 下载![](pdf.jpg) | 103000 | 5252 | AP | Label | 2016/01/26 | 下载![](pdf.jpg) | 103000 | 5251 | AP | Letter | 2013/01/23 | 下载![](pdf.jpg) | 103000 | 5251 | AP | Label | 2013/01/23 | 下载![](pdf.jpg) | 103000 | 5244 | AP | Label | 2015/08/07 | 下载![](pdf.jpg) | 103000 | 5244 | AP | Letter | 2015/08/10 | 下载![](pdf.jpg) | 103000 | 5236 | AP | Label | 2011/07/08 | 下载![](pdf.jpg) | 103000 | 5232 | AP | Label | 2011/08/30 | 下载![](pdf.jpg) | 103000 | 5232 | AP | Letter | 2011/08/30 | 下载![](pdf.jpg) | 103000 | 5232 | AP | Review | 2015/09/23 | 下载![](pdf.jpg) | 103000 | 5215 | AP | Review | 2013/08/09 | 下载![](pdf.jpg) | 103000 | 5215 | AP | Label | 2010/10/19 | 下载![](pdf.jpg) | 103000 | 5215 | AP | Letter | 2010/10/20 | 下载![](pdf.jpg) | 103000 | 5210 | AP | Letter | 2009/08/07 | 下载![](pdf.jpg) | 103000 | 5210 | AP | Label | 2009/08/07 | 下载![](pdf.jpg) | 103000 | 5209 | AP | Letter | 2009/08/07 | 下载![](pdf.jpg) | 103000 | 5209 | AP | Label | 2009/08/07 | 下载![](pdf.jpg) | 103000 | 5189 | AP | Review | 2013/10/23 | 下载![](pdf.jpg) | 103000 | 5189 | AP | Label | 2010/03/17 | 下载![](pdf.jpg) | 103000 | 5189 | AP | Letter | 2010/03/18 | 下载![](pdf.jpg) | 103000 | 5050 | AP | Letter | 2004/07/21 | 下载![](pdf.jpg) | 103000 | 5050 | AP | Label | 2004/09/15 | 下载![](pdf.jpg) | 103000 | 5000 | AP | Letter | 2004/03/11 | 下载 | 103000 | 5000 | AP | Label | 2004/03/11 | 下载![](pdf.jpg) | 103000 | 5000 | AP | Review | 2004/03/11 | 下载 | 103000 | 1004 | AP | Letter | 2004/03/11 | 下载 | 103000 | 1004 | AP | Review | 2004/03/11 | 下载 | 103000 | 0000 | AP | Other Important Information from FDA | 2008/08/12 | 下载 | 103000 | 0000 | AP | Medication Guide | 2009/11/16 | 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 | 103000 | 5294 | AP | 2016/02/04 | Labeling Revision | 103000 | 5292 | AP | 2015/08/11 | Labeling Revision | 103000 | 5282 | AP | 2015/04/17 | Efficacy Supplement with Clinical Data to Support | 103000 | 5280 | AP | 2014/05/07 | Labeling Revision | 103000 | 5260 | AP | 2013/09/11 | Efficacy Supplement with Clinical Data to Support | 103000 | 5256 | AP | 2012/07/16 | Labeling Revision | 103000 | 5253 | AP | 2012/11/09 | Labeling Revision | 103000 | 5252 | AP | 2016/01/21 | Efficacy Supplement with Clinical Data to Support | 103000 | 5251 | AP | 2013/01/18 | Efficacy Supplement with Clinical Data to Support | 103000 | 5244 | AP | 2015/08/05 | Labeling Revision | 103000 | 5236 | AP | 2011/06/23 | Supplement | 103000 | 5232 | AP | 2011/08/24 | Supplement | 103000 | 5219 | AP | 2010/06/03 | Supplement | 103000 | 5215 | AP | 2010/10/15 | Supplement | 103000 | 5210 | AP | 2009/07/31 | Supplement | 103000 | 5209 | AP | 2009/07/31 | Supplement | 103000 | 5197 | AP | 2009/08/21 | Supplement | 103000 | 5189 | AP | 2010/03/09 | Supplement | 103000 | 5184 | AP | 2008/08/06 | Supplement | 103000 | 5171 | AP | 2008/03/21 | Supplement | 103000 | 5165 | AP | 2007/09/06 | Supplement | 103000 | 5160 | AP | 2007/08/23 | Supplement | 103000 | 5159 | AP | 2007/06/18 | Supplement | 103000 | 5156 | AP | 2007/04/26 | Supplement | 103000 | 5151 | AP | 2007/03/01 | Supplement | 103000 | 5148 | AP | 2006/09/28 | Supplement | 103000 | 5144 | AP | 2006/08/17 | Supplement | 103000 | 5122 | AP | 2005/11/10 | Supplement | 103000 | 5120 | AP | 2010/03/26 | Supplement | 103000 | 5101 | AP | 2005/04/14 | Supplement | 103000 | 5097 | AP | 2005/03/11 | Supplement | 103000 | 5050 | AP | 2004/07/19 | Supplement | 103000 | 5000 | AP | 2002/04/12 | Supplement | 103000 | 1004 | AP | 2000/12/21 | Supplement | 103000 | 0000 | AP | 1991/12/09 | Approval |
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