药品名称 | REMICADE | 申请号 | 103772 | 产品号 | 001 | 活性成分 | INFLIXIMAB | 市场状态 | 处方药 | 剂型或给药途径 | VIAL | 规格 | 100MG | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | | 申请机构 | CENTOCOR 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 | 103772 | 5374 | AP | Label | 2015/08/28 | 下载 | 103772 | 5374 | AP | Letter | 2015/09/01 | 下载 | 103772 | 5373 | AP | Letter | 2015/10/06 | 下载 | 103772 | 5373 | AP | Label | 2015/10/08 | 下载 | 103772 | 5370 | AP | Label | 2015/01/05 | 下载 | 103772 | 5370 | AP | Letter | 2015/01/07 | 下载 | 103772 | 5359 | AP | Letter | 2013/11/08 | 下载 | 103772 | 5359 | AP | Label | 2013/11/08 | 下载 | 103772 | 5345 | AP | Letter | 2013/03/29 | 下载 | 103772 | 5345 | AP | Label | 2013/04/01 | 下载 | 103772 | 5328 | AP | Letter | 2012/06/29 | 下载 | 103772 | 5317 | AP | Letter | 2011/08/11 | 下载 | 103772 | 5301 | AP | Letter | 2011/09/29 | 下载 | 103772 | 5301 | AP | Medication Guide | 2011/09/30 | 下载 | 103772 | 5301 | AP | Label | 2011/09/30 | 下载 | 103772 | 5295 | AP | Label | 2012/03/15 | 下载 | 103772 | 5281 | AP | Letter | 2011/02/28 | 下载 | 103772 | 5281 | AP | Medication Guide | 2011/03/04 | 下载 | 103772 | 5281 | AP | Label | 2011/03/04 | 下载 | 103772 | 5278 | AP | Letter | 2010/08/03 | 下载 | 103772 | 5260 | AP | Label | 2010/05/07 | 下载 | 103772 | 5260 | AP | Letter | 2010/05/10 | 下载 | 103772 | 5259 | AP | Letter | 2011/01/06 | 下载 | 103772 | 5259 | AP | Label | 2011/01/06 | 下载 | 103772 | 5258 | AP | Letter | 2009/11/25 | 下载 | 103772 | 5258 | AP | Label | 2010/08/28 | 下载 | 103772 | 5234 | AP | Label | 2009/05/07 | 下载 | 103772 | 5234 | AP | Letter | 2009/05/08 | 下载 | 103772 | 5232 | AP | Label | 2009/04/20 | 下载 | 103772 | 5232 | AP | Letter | 2009/04/20 | 下载 | 103772 | 5189 | AP | Letter | 2007/07/05 | 下载 | 103772 | 5189 | AP | Label | 2007/07/05 | 下载 | 103772 | 5189 | AP | Review | 2012/02/14 | 下载 | 103772 | 5167 | AP | Label | 2006/08/18 | 下载 | 103772 | 5167 | AP | Letter | 2006/08/14 | 下载 | 103772 | 5166 | AP | Label | 2006/08/18 | 下载 | 103772 | 5166 | AP | Letter | 2006/08/14 | 下载 | 103772 | 5163 | AP | Letter | 2007/01/08 | 下载 | 103772 | 5163 | AP | Label | 2007/01/08 | 下载 | 103772 | 5160 | AP | Letter | 2007/04/25 | 下载 | 103772 | 5160 | AP | Label | 2007/04/25 | 下载 | 103772 | 5145 | AP | Label | 2006/10/23 | 下载 | 103772 | 5145 | AP | Letter | 2006/10/23 | 下载 | 103772 | 5138 | AP | Letter | 2006/05/19 | 下载 | 103772 | 5138 | AP | Label | 2006/05/19 | 下载 | 103772 | 5129 | AP | Letter | 2007/02/12 | 下载 | 103772 | 5129 | AP | Label | 2007/02/23 | 下载 | 103772 | 5113 | AP | Label | 2005/09/20 | 下载 | 103772 | 5113 | AP | Letter | 2005/10/20 | 下载 | 103772 | 5113 | AP | Review | 2016/01/19 | 下载 | 103772 | 5092 | AP | Letter | 2005/04/12 | 下载 | 103772 | 5092 | AP | Label | 2005/04/12 | 下载 | 103772 | 5090 | AP | Letter | 2005/03/03 | 下载 | 103772 | 5089 | AP | Letter | 2005/05/20 | 下载 | 103772 | 5089 | AP | Label | 2005/05/20 | 下载 | 103772 | 5077 | AP | Letter | 2004/12/29 | 下载 | 103772 | 5077 | AP | Label | 2004/12/29 | 下载 | 103772 | 5073 | AP | Label | 2004/09/29 | 下载 | 103772 | 5073 | AP | Patient Package Insert | 2004/09/29 | 下载 | 103772 | 5073 | AP | Letter | 2004/10/05 | 下载 | 103772 | 5058 | AP | Letter | 2004/08/10 | 下载 | 103772 | 5058 | AP | Label | 2004/08/10 | 下载 | 103772 | 5056 | AP | Letter | 2003/11/03 | 下载 | 103772 | 5056 | AP | Review | 2008/04/02 | 下载 | 103772 | 5032 | AP | Letter | 2004/03/26 | 下载 | 103772 | 5020 | AP | Letter | 2003/11/03 | 下载 | 103772 | 5012 | AP | Letter | 2004/03/26 | 下载 | 103772 | 5012 | AP | Label | 2004/03/26 | 下载 | 103772 | 5004 | AP | Letter | 2004/03/26 | 下载 | 103772 | 5004 | AP | Label | 2004/03/26 | 下载 | 103772 | 1007 | AP | Letter | 2004/03/26 | 下载 | 103772 | 1007 | AP | Label | 2004/03/26 | 下载 | 103772 | 1007 | AP | Review | 2007/08/06 | 下载 | 103772 | 1004 | AP | Review | 2004/03/26 | 下载 | 103772 | 1004 | AP | Letter | 2004/03/26 | 下载 | 103772 | 1004 | AP | Label | 2004/03/26 | 下载 | 103772 | 0000 | AP | Review | 2004/09/22 | 下载 | 103772 | 0000 | AP | Label | 2004/09/22 | 下载 | 103772 | 0000 | AP | Letter | 2004/09/22 | 下载 | 103772 | 0000 | AP | Other Important Information from FDA | 2006/05/19 | 下载 | 103772 | 0000 | 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 | 103772 | 5374 | AP | 2015/08/27 | Labeling Revision | 103772 | 5373 | AP | 2015/10/02 | Labeling Revision | 103772 | 5370 | AP | 2015/01/02 | Labeling Revision | 103772 | 5359 | AP | 2013/11/06 | Labeling Revision | 103772 | 5359 | AP | 2013/11/06 | Labeling Revision | 103772 | 5345 | AP | 2013/03/28 | Labeling Revision | 103772 | 5328 | AP | 2012/06/28 | Labeling Revision | 103772 | 5317 | AP | 2011/08/01 | Supplement | 103772 | 5301 | AP | 2011/09/23 | Supplement | 103772 | 5295 | AP | 2011/10/26 | Supplement | 103772 | 5281 | AP | 2011/02/23 | Supplement | 103772 | 5278 | AP | 2010/07/29 | Supplement | 103772 | 5260 | AP | 2010/04/26 | Supplement | 103772 | 5259 | AP | 2010/12/29 | Supplement | 103772 | 5258 | AP | 2009/11/18 | Supplement | 103772 | 5234 | AP | 2009/05/05 | Supplement | 103772 | 5232 | AP | 2008/12/22 | Supplement | 103772 | 5189 | AP | 2007/06/12 | Supplement | 103772 | 5167 | AP | 2006/08/11 | Supplement | 103772 | 5166 | AP | 2006/08/11 | Supplement | 103772 | 5163 | AP | 2006/12/08 | Supplement | 103772 | 5160 | AP | 2007/04/19 | Supplement | 103772 | 5145 | AP | 2006/10/13 | Supplement | 103772 | 5138 | AP | 2006/05/19 | Supplement | 103772 | 5129 | AP | 2006/09/26 | Supplement | 103772 | 5113 | AP | 2005/09/15 | Supplement | 103772 | 5092 | AP | 2005/04/05 | Supplement | 103772 | 5090 | AP | 2004/12/17 | Supplement | 103772 | 5089 | AP | 2005/05/18 | Supplement | 103772 | 5077 | AP | 2004/12/17 | Supplement | 103772 | 5073 | AP | 2004/09/29 | Supplement | 103772 | 5058 | AP | 2004/07/29 | Supplement | 103772 | 5056 | AP | 2003/09/03 | Supplement | 103772 | 5032 | AP | 2003/04/01 | Supplement | 103772 | 5020 | AP | 2003/09/03 | Supplement | 103772 | 5012 | AP | 2002/06/28 | Supplement | 103772 | 5004 | AP | 2002/02/27 | Supplement | 103772 | 1007 | AP | 2000/12/29 | Supplement | 103772 | 1004 | AP | 1999/11/10 | Supplement | 103772 | 0000 | AP | 1998/08/24 | Approval |
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