| 药品名称 | OXYCONTIN | | 申请号 | 022272 | 产品号 | 003 | | 活性成分 | OXYCODONE HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET, EXTENDED RELEASE;ORAL | 规格 | 20MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2010/04/05 | 申请机构 | PURDUE PHARMA LP
| | 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 | | NPP | 2018/08/13 | | M-153 | 2016/04/16 | | 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 | | 022272 | 036 | AP | Letter | 2016/10/04 | 下载 | | 022272 | 028 | AP | Letter | 2015/07/06 | 下载 | | 022272 | 027 | AP | Letter | 2015/08/13 | 下载 | | 022272 | 027 | AP | Label | 2015/08/13 | 下载 | | 022272 | 027 | AP | Review | 2015/09/29 | 下载 | | 022272 | 024 | AP | Letter | 2014/08/20 | 下载 | | 022272 | 023 | AP | Letter | 2014/10/30 | 下载 | | 022272 | 023 | AP | Label | 2014/10/30 | 下载 | | 022272 | 022 | AP | Label | 2014/04/16 | 下载 | | 022272 | 022 | AP | Letter | 2014/04/17 | 下载 | | 022272 | 017 | AP | Letter | 2013/04/16 | 下载 | | 022272 | 016 | AP | Letter | 2013/01/14 | 下载 | | 022272 | 016 | AP | Label | 2013/01/15 | 下载 | | 022272 | 014 | AP | Letter | 2013/04/16 | 下载 | | 022272 | 014 | AP | Label | 2013/04/16 | 下载 | | 022272 | 014 | AP | Review | 2013/04/26 | 下载 | | 022272 | 011 | AP | Label | 2012/07/13 | 下载 | | 022272 | 011 | AP | Letter | 2012/07/11 | 下载 | | 022272 | 010 | AP | Label | 2012/07/12 | 下载 | | 022272 | 010 | AP | Letter | 2012/07/11 | 下载 | | 022272 | 009 | AP | Letter | 2011/10/11 | 下载 | | 022272 | 009 | AP | Label | 2011/10/12 | 下载 | | 022272 | 006 | AP | Letter | 2010/11/22 | 下载 | | 022272 | 006 | AP | Label | 2010/11/26 | 下载 | | 022272 | 005 | AP | Letter | 2010/07/01 | 下载 | | 022272 | 005 | AP | Label | 2010/07/01 | 下载 | | 022272 | 000 | AP | Other | 2010/08/06 | 下载 | | 022272 | 000 | AP | Review | 2010/09/29 | 下载 | | 022272 | 000 | AP | Summary Review | 2011/02/17 | 下载 | | 022272 | 000 | AP | Label | 2010/04/06 | 下载 | | 022272 | 000 | AP | Letter | 2010/04/09 | 下载 | | 022272 | 000 | AP | Medication Guide | 2010/04/16 | 下载 | | 022272 | 000 | AP | Other Important Information from FDA | 2013/02/15 | 下载 | | 022272 | 000 | AP | Other | 2015/11/04 | 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 | | 022272 | 036 | AP | 2016/09/30 | Supplement | | 022272 | 033 | AP | 2016/04/20 | Supplement | | 022272 | 032 | AP | 2016/03/28 | Manufacturing Change or Addition | | 022272 | 031 | AP | 2016/03/25 | Manufacturing Change or Addition | | 022272 | 030 | AP | 2015/11/12 | Manufacturing Change or Addition | | 022272 | 029 | AP | 2015/09/10 | Manufacturing Change or Addition | | 022272 | 028 | AP | 2015/06/26 | Supplement | | 022272 | 027 | AP | 2015/08/13 | Efficacy Supplement with Clinical Data to Support | | 022272 | 025 | AP | 2014/10/13 | Manufacturing Change or Addition | | 022272 | 024 | AP | 2014/08/19 | Supplement | | 022272 | 023 | AP | 2014/10/22 | Labeling Revision | | 022272 | 022 | AP | 2014/04/16 | Labeling Revision | | 022272 | 020 | AP | 2014/01/31 | Manufacturing Change or Addition | | 022272 | 017 | AP | 2013/04/15 | Supplement | | 022272 | 016 | AP | 2013/01/11 | Labeling Revision | | 022272 | 015 | AP | 2014/02/04 | Manufacturing Change or Addition | | 022272 | 014 | AP | 2013/04/16 | Labeling Revision | | 022272 | 011 | AP | 2012/07/09 | Labeling Revision | | 022272 | 010 | AP | 2012/07/09 | Labeling Revision | | 022272 | 009 | AP | 2011/10/05 | Labeling Revision | | 022272 | 006 | AP | 2010/11/15 | Labeling Revision | | 022272 | 005 | AP | 2010/06/29 | Labeling Revision | | 022272 | 000 | AP | 2010/04/05 | Approval |
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