| 药品名称 | EPOGEN/PROCRIT | | 申请号 | 103234 | 产品号 | 002 | | 活性成分 | EPOETIN ALFA | 市场状态 | 处方药 | | 剂型或给药途径 | VIAL; MULTIDOSE | 规格 | 20,000U/2ML | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | | 申请机构 | AMGEN | | 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 | | 103234 | 5329 | AP | Letter | 2013/03/29 | 下载 | | 103234 | 5323 | AP | Letter | 2014/01/02 | 下载 | | 103234 | 5323 | AP | Label | 2014/01/07 | 下载 | | 103234 | 5281 | AP | Label | 2012/06/06 | 下载 | | 103234 | 5281 | AP | Letter | 2012/06/07 | 下载 | | 103234 | 5266 | AP | Letter | 2011/06/24 | 下载 | | 103234 | 5266 | AP | Label | 2011/06/24 | 下载 | | 103234 | 5256 | AP | Letter | 2011/06/24 | 下载 | | 103234 | 5232 | AP | Label | 2010/02/04 | 下载 | | 103234 | 5221 | AP | Label | 2010/02/04 | 下载 | | 103234 | 5221 | AP | Letter | 2010/02/05 | 下载 | | 103234 | 5199 | AP | Label | 2010/02/16 | 下载 | | 103234 | 5199 | AP | Letter | 2010/02/16 | 下载 | | 103234 | 5196 | AP | Label | 2008/11/25 | 下载 | | 103234 | 5196 | AP | Letter | 2011/04/28 | 下载 | | 103234 | 5195 | AP | Label | 2008/11/25 | 下载 | | 103234 | 5195 | AP | Letter | 2011/04/28 | 下载 | | 103234 | 5166 | AP | Summary Review | 2012/05/25 | 下载 | | 103234 | 5166 | AP | Letter | 2011/06/24 | 下载 | | 103234 | 5166 | AP | Label | 2011/06/24 | 下载 | | 103234 | 5166 | AP | Review | 2012/07/16 | 下载 | | 103234 | 5164 | AP | Label | 2008/03/11 | 下载 | | 103234 | 5164 | AP | Patient Package Insert | 2008/03/12 | 下载 | | 103234 | 5163 | AP | Label | 2008/01/30 | 下载 | | 103234 | 5163 | AP | Letter | 2008/01/31 | 下载 | | 103234 | 5158 | AP | Letter | 2007/11/08 | 下载 | | 103234 | 5158 | AP | Label | 2007/11/08 | 下载 | | 103234 | 5158 | AP | Patient Package Insert | 2007/11/08 | 下载 | | 103234 | 5122 | AP | Label | 2007/03/09 | 下载 | | 103234 | 5122 | AP | Letter | 2007/03/15 | 下载 | | 103234 | 5104 | AP | Letter | 2006/05/18 | 下载 | | 103234 | 5104 | AP | Label | 2006/05/18 | 下载 | | 103234 | 5093 | AP | Letter | 2005/12/16 | 下载 | | 103234 | 5093 | AP | Label | 2005/12/16 | 下载 | | 103234 | 5093 | AP | Review | 2007/09/26 | 下载 | | 103234 | 5076 | AP | Review | 2007/09/26 | 下载 | | 103234 | 5076 | AP | Letter | 2005/01/26 | 下载 | | 103234 | 5076 | AP | Label | 2005/01/26 | 下载 | | 103234 | 5053 | AP | Letter | 2004/07/07 | 下载 | | 103234 | 5053 | AP | Label | 2004/07/14 | 下载 | | 103234 | 5053 | AP | Review | 2007/09/26 | 下载 | | 103234 | 5033 | AP | Review | 2007/09/26 | 下载 | | 103234 | 5033 | AP | Letter | 2004/05/21 | 下载 | | 103234 | 1046 | AP | Letter | 2007/03/23 | 下载 | | 103234 | 1046 | AP | Label | 2007/03/23 | 下载 | | 103234 | 1046 | AP | Review | 2007/03/23 | 下载 | | 103234 | 1015 | AP | Label | 2007/06/04 | 下载 | | 103234 | 0000 | AP | Other | 2010/02/16 | 下载 | | 103234 | 0000 | AP | Other | 2010/02/05 | 下载 | | 103234 | 0000 | AP | Other | 2010/02/05 | 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 | | 103234 | 5329 | AP | 2013/03/27 | Labeling Revision | | 103234 | 5323 | AP | 2013/12/31 | Labeling Revision | | 103234 | 5281 | AP | 2012/05/31 | Supplement | | 103234 | 5266 | AP | 2011/06/24 | Supplement | | 103234 | 5256 | AP | 2011/06/24 | Supplement | | 103234 | 5232 | AP | 2010/01/11 | Supplement | | 103234 | 5221 | AP | 2009/10/13 | Supplement | | 103234 | 5199 | AP | 2010/02/16 | Supplement | | 103234 | 5196 | AP | 2008/11/19 | Supplement | | 103234 | 5195 | AP | 2008/11/19 | Supplement | | 103234 | 5166 | AP | 2011/06/24 | Supplement | | 103234 | 5164 | AP | 2008/03/07 | Supplement | | 103234 | 5163 | AP | 2007/12/17 | Supplement | | 103234 | 5158 | AP | 2007/11/08 | Supplement | | 103234 | 5122 | AP | 2007/03/09 | Supplement | | 103234 | 5104 | AP | 2006/05/11 | Supplement | | 103234 | 5093 | AP | 2005/10/26 | Supplement | | 103234 | 5082 | AP | 2005/10/27 | Supplement | | 103234 | 5076 | AP | 2004/11/10 | Supplement | | 103234 | 5053 | AP | 2004/06/30 | Supplement | | 103234 | 5034 | AP | 2003/05/07 | Supplement | | 103234 | 5033 | AP | 2004/05/21 | Supplement | | 103234 | 1062 | AP | 2000/09/29 | Supplement | | 103234 | 1058 | AP | 2004/10/19 | Supplement | | 103234 | 1046 | AP | 1999/07/26 | Supplement | | 103234 | 1036 | AP | 1996/12/23 | Supplement | | 103234 | 1016 | AP | 1994/06/29 | Supplement | | 103234 | 1015 | AP | 1993/04/01 | Supplement | | 103234 | 1009 | AP | 1990/12/31 | Supplement | | 103234 | 0000 | AP | 1989/06/01 | Approval |
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