| 药品名称 | JUVISYNC | | 申请号 | 202343 | 产品号 | 004 | | 活性成分 | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2012/09/18 | 申请机构 | MERCK SHARP AND DOHME CORP
| | 化学类型 | New combination | 审评分类 | Standard 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 | | 202343 | 011 | AP | Label | 2014/02/25 | 下载 | | 202343 | 011 | AP | Letter | 2014/02/26 | 下载 | | 202343 | 010 | AP | Label | 2013/08/19 | 下载 | | 202343 | 010 | AP | Letter | 2013/08/22 | 下载 | | 202343 | 008 | AP | Letter | 2013/10/28 | 下载 | | 202343 | 008 | AP | Label | 2013/10/31 | 下载 | | 202343 | 007 | AP | Label | 2012/11/06 | 下载 | | 202343 | 007 | AP | Letter | 2012/11/06 | 下载 | | 202343 | 006 | AP | Label | 2013/02/11 | 下载 | | 202343 | 006 | AP | Letter | 2013/02/13 | 下载 | | 202343 | 005 | AP | Label | 2012/11/06 | 下载 | | 202343 | 005 | AP | Letter | 2012/11/06 | 下载 | | 202343 | 004 | AP | Letter | 2012/09/24 | 下载 | | 202343 | 004 | AP | Medication Guide | 2012/09/20 | 下载 | | 202343 | 004 | AP | Label | 2012/09/20 | 下载 | | 202343 | 002 | AP | Label | 2012/09/20 | 下载 | | 202343 | 002 | AP | Medication Guide | 2012/09/20 | 下载 | | 202343 | 002 | AP | Letter | 2012/09/24 | 下载 | | 202343 | 001 | AP | Letter | 2012/09/24 | 下载 | | 202343 | 001 | AP | Label | 2012/09/20 | 下载 | | 202343 | 001 | AP | Medication Guide | 2012/09/20 | 下载 | | 202343 | 000 | AP | Letter | 2011/10/07 | 下载 | | 202343 | 000 | AP | Label | 2011/10/07 | 下载 | | 202343 | 000 | AP | Medication Guide | 2011/10/07 | 下载 | | 202343 | 000 | AP | Review | 2012/07/13 | 下载 | | 202343 | 000 | AP | Summary Review | 2012/07/13 | 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 | | 202343 | 011 | AP | 2014/02/24 | Labeling Revision | | 202343 | 010 | AP | 2013/08/19 | Labeling Revision | | 202343 | 009 | AP | 2013/11/08 | Manufacturing Change or Addition | | 202343 | 008 | AP | 2013/10/25 | Labeling Revision | | 202343 | 007 | AP | 2012/10/31 | Labeling Revision | | 202343 | 006 | AP | 2013/02/11 | Labeling Revision | | 202343 | 005 | AP | 2012/10/31 | Labeling Revision | | 202343 | 004 | AP | 2012/09/18 | Labeling Revision | | 202343 | 002 | AP | 2012/09/18 | Labeling Revision | | 202343 | 001 | AP | 2012/09/18 | Efficacy Supplement with Clinical Data to Support | | 202343 | 000 | AP | 2011/10/07 | Approval |
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