药品名称 | ATRIPLA | 申请号 | 021937 | 产品号 | 001 | 活性成分 | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL | 规格 | 600MG;200MG;300MG | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 2006/07/12 | 申请机构 | GILEAD SCIENCES INC
| 化学类型 | New combination | 审评分类 | Priority review drug |
|
|
|
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 | NCE | 2008/07/02 | PED | 2009/01/02 |
|
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 | 021937 | 039 | AP | Letter | 2016/02/12 | 下载 | 021937 | 039 | AP | Label | 2016/02/18 | 下载 | 021937 | 037 | AP | Letter | 2015/11/23 | 下载 | 021937 | 037 | AP | Label | 2015/12/03 | 下载 | 021937 | 034 | AP | Letter | 2015/01/26 | 下载 | 021937 | 034 | AP | Label | 2015/01/29 | 下载 | 021937 | 031 | AP | Letter | 2013/10/25 | 下载 | 021937 | 031 | AP | Label | 2013/10/25 | 下载 | 021937 | 027 | AP | Label | 2013/04/19 | 下载 | 021937 | 027 | AP | Letter | 2013/04/23 | 下载 | 021937 | 025 | AP | Letter | 2012/06/18 | 下载 | 021937 | 025 | AP | Label | 2012/06/18 | 下载 | 021937 | 023 | AP | Letter | 2011/09/20 | 下载 | 021937 | 023 | AP | Label | 2011/09/20 | 下载 | 021937 | 019 | AP | Label | 2010/08/10 | 下载 | 021937 | 019 | AP | Letter | 2010/08/11 | 下载 | 021937 | 012 | AP | Label | 2010/01/08 | 下载 | 021937 | 012 | AP | Letter | 2010/01/15 | 下载 | 021937 | 011 | AP | Letter | 2008/10/23 | 下载 | 021937 | 009 | AP | Letter | 2008/06/09 | 下载 | 021937 | 009 | AP | Label | 2008/06/12 | 下载 | 021937 | 007 | AP | Letter | 2008/03/04 | 下载 | 021937 | 007 | AP | Label | 2008/03/05 | 下载 | 021937 | 006 | AP | Letter | 2008/02/20 | 下载 | 021937 | 006 | AP | Label | 2008/02/25 | 下载 | 021937 | 000 | AP | Label | 2006/07/12 | 下载 | 021937 | 000 | AP | Letter | 2006/07/21 | 下载 | 021937 | 000 | AP | Review | 2006/12/13 | 下载 |
|
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 | 021937 | 039 | AP | 2016/02/11 | Labeling Revision | 021937 | 037 | AP | 2015/11/20 | Labeling Revision | 021937 | 035 | AP | 2015/01/12 | Manufacturing Change or Addition | 021937 | 034 | AP | 2015/01/23 | Labeling Revision | 021937 | 033 | AP | 2014/11/26 | Manufacturing Change or Addition | 021937 | 032 | AP | 2014/07/11 | Manufacturing Change or Addition | 021937 | 031 | AP | 2013/10/23 | Labeling Revision | 021937 | 030 | AP | 2013/11/08 | Manufacturing Change or Addition | 021937 | 027 | AP | 2013/04/17 | Labeling Revision | 021937 | 025 | AP | 2012/06/14 | Labeling Revision | 021937 | 023 | AP | 2011/09/16 | Labeling Revision | 021937 | 019 | AP | 2010/08/06 | Labeling Revision | 021937 | 012 | AP | 2010/01/07 | Efficacy Supplement with Clinical Data to Support | 021937 | 011 | AP | 2008/10/18 | Package Change | 021937 | 009 | AP | 2008/06/06 | Efficacy Supplement with Clinical Data to Support | 021937 | 007 | AP | 2008/02/28 | Labeling Revision | 021937 | 006 | AP | 2008/02/15 | Labeling Revision | 021937 | 000 | AP | 2006/07/12 | Approval |
|