药品名称 | OPANA ER | 申请号 | 201655 | 产品号 | 003 | 活性成分 | OXYMORPHONE HYDROCHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET, EXTENDED RELEASE;ORAL | 规格 | 10MG | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 2011/12/09 | 申请机构 | ENDO PHARMACEUTICALS INC
| 化学类型 | New formulation or new manufacturer | 审评分类 | Priority review drug |
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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 | 201655 | 022 | AP | Letter | 2016/10/03 | 下载 | 201655 | 020 | AP | Letter | 2016/04/22 | 下载 | 201655 | 017 | AP | Letter | 2015/07/07 | 下载 | 201655 | 016 | AP | Medication Guide | 2016/03/30 | 下载 | 201655 | 016 | AP | Letter | 2015/01/29 | 下载 | 201655 | 016 | AP | Label | 2015/01/30 | 下载 | 201655 | 015 | AP | Letter | 2014/08/20 | 下载 | 201655 | 012 | AP | Label | 2014/04/16 | 下载 | 201655 | 012 | AP | Letter | 2014/04/17 | 下载 | 201655 | 005 | AP | Letter | 2013/04/18 | 下载 | 201655 | 004 | AP | Label | 2013/01/14 | 下载 | 201655 | 004 | AP | Letter | 2013/01/16 | 下载 | 201655 | 002 | AP | Letter | 2012/07/11 | 下载 | 201655 | 002 | AP | Label | 2012/07/12 | 下载 | 201655 | 000 | AP | Review | 2012/08/27 | 下载 | 201655 | 000 | AP | Summary Review | 2012/08/27 | 下载 | 201655 | 000 | AP | Letter | 2011/12/09 | 下载 | 201655 | 000 | AP | Label | 2011/12/09 | 下载 | 201655 | 000 | AP | Other | 2012/01/05 | 下载 | 201655 | 000 | AP | Medication Guide | 2012/07/11 | 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 | 201655 | 022 | AP | 2016/09/30 | Supplement | 201655 | 020 | AP | 2016/04/20 | Supplement | 201655 | 019 | AP | 2016/02/22 | Manufacturing Change or Addition | 201655 | 018 | AP | 2015/08/24 | Manufacturing Change or Addition | 201655 | 017 | AP | 2015/06/26 | Supplement | 201655 | 016 | AP | 2015/01/28 | Labeling Revision | 201655 | 015 | AP | 2014/08/19 | Supplement | 201655 | 014 | AP | 2014/09/23 | Manufacturing Change or Addition | 201655 | 013 | AP | 2014/05/15 | Manufacturing Change or Addition | 201655 | 012 | AP | 2014/04/16 | Labeling Revision | 201655 | 010 | AP | 2013/12/05 | Labeling Revision | 201655 | 007 | AP | 2013/05/29 | Manufacturing Change or Addition | 201655 | 006 | AP | 2013/05/13 | Manufacturing Change or Addition | 201655 | 005 | AP | 2013/04/15 | Labeling Revision | 201655 | 004 | AP | 2013/01/14 | Labeling Revision | 201655 | 002 | AP | 2012/07/09 | Labeling Revision | 201655 | 000 | AP | 2011/12/09 | Approval |
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