药品名称 | ENBREL | 申请号 | 103795 | 产品号 | 002 | 活性成分 | ETANERCEPT | 市场状态 | 处方药 | 剂型或给药途径 | SYRINGE | 规格 | 50MG/ML | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | | 申请机构 | IMMUNEX | 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 | 103795 | 5548 | AP | Letter | 2015/03/26 | 下载![](pdf.jpg) | 103795 | 5548 | AP | Label | 2015/03/26 | 下载![](pdf.jpg) | 103795 | 5532 | AP | Label | 2015/03/24 | 下载![](pdf.jpg) | 103795 | 5531 | AP | Letter | 2013/11/18 | 下载![](pdf.jpg) | 103795 | 5531 | AP | Label | 2013/11/22 | 下载![](pdf.jpg) | 103795 | 5507 | AP | Letter | 2012/12/13 | 下载![](pdf.jpg) | 103795 | 5507 | AP | Label | 2012/12/14 | 下载![](pdf.jpg) | 103795 | 5507 | AP | Medication Guide | 2012/12/14 | 下载![](pdf.jpg) | 103795 | 5503 | AP | Label | 2012/12/05 | 下载![](pdf.jpg) | 103795 | 5503 | AP | Letter | 2012/12/05 | 下载![](pdf.jpg) | 103795 | 5475 | AP | Letter | 2011/09/13 | 下载![](pdf.jpg) | 103795 | 5445 | AP | Letter | 2010/11/04 | 下载![](pdf.jpg) | 103795 | 5443 | AP | Letter | 2010/10/19 | 下载![](pdf.jpg) | 103795 | 5437 | AP | Letter | 2010/08/02 | 下载![](pdf.jpg) | 103795 | 5431 | AP | Letter | 2011/01/27 | 下载![](pdf.jpg) | 103795 | 5415 | AP | Label | 2011/01/11 | 下载![](pdf.jpg) | 103795 | 5415 | AP | Letter | 2009/12/03 | 下载![](pdf.jpg) | 103795 | 5400 | AP | Letter | 2010/06/29 | 下载![](pdf.jpg) | 103795 | 5397 | AP | Letter | 2010/06/29 | 下载![](pdf.jpg) | 103795 | 5391 | AP | Letter | 2010/06/29 | 下载![](pdf.jpg) | 103795 | 5359 | AP | Label | 2008/09/08 | 下载![](pdf.jpg) | 103795 | 5359 | AP | Letter | 2008/09/09 | 下载![](pdf.jpg) | 103795 | 5356 | AP | Label | 2008/05/29 | 下载![](pdf.jpg) | 103795 | 5322 | AP | Label | 2007/03/14 | 下载![](pdf.jpg) | 103795 | 5322 | AP | Letter | 2007/03/15 | 下载![](pdf.jpg) | 103795 | 5286 | AP | Label | 2006/08/31 | 下载![](pdf.jpg) | 103795 | 5229 | AP | Letter | 2005/08/08 | 下载![](pdf.jpg) | 103795 | 5229 | AP | Label | 2005/08/08 | 下载![](pdf.jpg) | 103795 | 5225 | AP | Letter | 2005/07/21 | 下载![](pdf.jpg) | 103795 | 5225 | AP | Label | 2005/07/21 | 下载![](pdf.jpg) | 103795 | 5191 | AP | Letter | 2005/06/07 | 下载![](pdf.jpg) | 103795 | 5191 | AP | Label | 2005/06/07 | 下载![](pdf.jpg) | 103795 | 5184 | AP | Letter | 2004/11/08 | 下载![](pdf.jpg) | 103795 | 5184 | AP | Label | 2004/11/08 | 下载![](pdf.jpg) | 103795 | 5162 | AP | Label | 2004/10/21 | 下载![](pdf.jpg) | 103795 | 5162 | AP | Letter | 2004/10/26 | 下载![](pdf.jpg) | 103795 | 5149 | AP | Letter | 2004/06/08 | 下载![](pdf.jpg) | 103795 | 5149 | AP | Label | 2004/04/30 | 下载![](pdf.jpg) | 103795 | 5125 | AP | Letter | 2004/04/08 | 下载![](pdf.jpg) | 103795 | 5123 | AP | Review | 2005/12/06 | 下载 | 103795 | 5123 | AP | Letter | 2003/11/06 | 下载![](pdf.jpg) | 103795 | 5110 | AP | Letter | 2003/11/06 | 下载![](pdf.jpg) | 103795 | 5109 | AP | Letter | 2004/09/22 | 下载 | 103795 | 5109 | AP | Label | 2004/09/22 | 下载![](pdf.jpg) | 103795 | 5109 | AP | Review | 2008/07/31 | 下载![](pdf.jpg) | 103795 | 5102 | AP | Letter | 2003/11/06 | 下载![](pdf.jpg) | 103795 | 5102 | AP | Review | 2004/12/07 | 下载 | 103795 | 5099 | AP | Letter | 2003/11/05 | 下载![](pdf.jpg) | 103795 | 5097 | AP | Letter | 2003/11/05 | 下载![](pdf.jpg) | 103795 | 5097 | AP | Review | 2008/07/31 | 下载![](pdf.jpg) | 103795 | 5055 | AP | Letter | 2003/11/05 | 下载![](pdf.jpg) | 103795 | 5051 | AP | Letter | 2004/09/22 | 下载![](pdf.jpg) | 103795 | 5051 | AP | Label | 2004/09/22 | 下载![](pdf.jpg) | 103795 | 5051 | AP | Patient Package Insert | 2004/09/22 | 下载![](pdf.jpg) | 103795 | 5034 | AP | Review | 2004/09/22 | 下载 | 103795 | 5034 | AP | Letter | 2004/09/22 | 下载 | 103795 | 5034 | AP | Label | 2004/09/22 | 下载![](pdf.jpg) | 103795 | 1004 | AP | Letter | 2004/09/22 | 下载 | 103795 | 1004 | AP | Label | 2004/09/22 | 下载 | 103795 | 1001 | AP | Letter | 2004/09/22 | 下载 | 103795 | 1001 | AP | Review | 2004/09/22 | 下载 | 103795 | 0000 | AP | Review | 2004/09/22 | 下载 | 103795 | 0000 | AP | Letter | 2004/09/22 | 下载 | 103795 | 0000 | AP | Label | 2004/09/22 | 下载![](pdf.jpg) | 103795 | 0000 | AP | Healthcare Professional Sheet | 2008/09/04 | 下载 | 103795 | 0000 | AP | Medication Guide | 2009/11/18 | 下载![](pdf.jpg) | 103795 | 0000 | AP | Other Important Information from FDA | 2011/12/20 | 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 | 103795 | 5548 | AP | 2015/03/25 | Labeling Revision | 103795 | 5532 | AP | 2015/03/20 | Supplement | 103795 | 5531 | AP | 2013/11/15 | Labeling Revision | 103795 | 5507 | AP | 2012/12/10 | Labeling Revision | 103795 | 5503 | AP | 2012/12/04 | Labeling Revision | 103795 | 5475 | AP | 2011/09/07 | Supplement | 103795 | 5445 | AP | 2010/10/13 | Supplement | 103795 | 5443 | AP | 2010/09/29 | Supplement | 103795 | 5437 | AP | 2010/07/29 | Supplement | 103795 | 5431 | AP | 2011/01/25 | Supplement | 103795 | 5415 | AP | 2009/11/18 | Supplement | 103795 | 5400 | AP | 2010/06/03 | Supplement | 103795 | 5397 | AP | 2010/06/03 | Supplement | 103795 | 5391 | AP | 2010/06/03 | Supplement | 103795 | 5359 | AP | 2008/06/23 | Supplement | 103795 | 5356 | AP | 2008/03/21 | Supplement | 103795 | 5338 | AP | 2007/10/31 | Supplement | 103795 | 5336 | AP | 2007/08/02 | Supplement | 103795 | 5333 | AP | 2007/06/29 | Supplement | 103795 | 5328 | AP | 2007/06/21 | Supplement | 103795 | 5322 | AP | 2007/02/01 | Supplement | 103795 | 5317 | AP | 2006/12/08 | Supplement | 103795 | 5313 | AP | 2006/11/09 | Supplement | 103795 | 5310 | AP | 2006/11/02 | Supplement | 103795 | 5304 | AP | 2006/12/01 | Supplement | 103795 | 5302 | AP | 2006/12/01 | Supplement | 103795 | 5301 | AP | 2007/01/12 | Supplement | 103795 | 5296 | AP | 2006/11/02 | Supplement | 103795 | 5294 | AP | 2006/09/25 | Supplement | 103795 | 5289 | AP | 2006/04/26 | Supplement | 103795 | 5286 | AP | 2006/06/14 | Supplement | 103795 | 5285 | AP | 2006/06/16 | Supplement | 103795 | 5283 | AP | 2006/04/13 | Supplement | 103795 | 5278 | AP | 2006/04/04 | Supplement | 103795 | 5277 | AP | 2006/03/21 | Supplement | 103795 | 5274 | AP | 2006/04/04 | Supplement | 103795 | 5273 | AP | 2006/03/02 | Supplement | 103795 | 5271 | AP | 2006/03/23 | Supplement | 103795 | 5266 | AP | 2006/03/02 | Supplement | 103795 | 5262 | AP | 2006/02/16 | Supplement | 103795 | 5260 | AP | 2006/02/07 | Supplement | 103795 | 5259 | AP | 2006/01/24 | Supplement | 103795 | 5256 | AP | 2006/05/17 | Supplement | 103795 | 5229 | AP | 2005/07/28 | Supplement | 103795 | 5225 | AP | 2005/06/28 | Supplement | 103795 | 5191 | AP | 2005/05/27 | Supplement | 103795 | 5184 | AP | 2004/09/27 | Supplement | 103795 | 5162 | AP | 2004/09/24 | Supplement | 103795 | 5149 | AP | 2004/04/30 | Supplement | 103795 | 5125 | AP | 2003/11/25 | Supplement | 103795 | 5123 | AP | 2003/07/24 | Supplement | 103795 | 5110 | AP | 2003/10/17 | Supplement | 103795 | 5109 | AP | 2003/06/05 | Supplement | 103795 | 5102 | AP | 2003/08/21 | Supplement | 103795 | 5099 | AP | 2003/10/09 | Supplement | 103795 | 5097 | AP | 2003/07/24 | Supplement | 103795 | 5055 | AP | 2003/07/24 | Supplement | 103795 | 5051 | AP | 2002/09/12 | Supplement | 103795 | 5034 | AP | 2002/01/15 | Supplement | 103795 | 5016 | AP | 2002/01/15 | Supplement | 103795 | 1004 | AP | 2000/06/06 | Supplement | 103795 | 1001 | AP | 1999/05/27 | Supplement | 103795 | 0000 | AP | 1998/11/02 | Approval |
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