| 药品名称 | ZORVOLEX | | 申请号 | 204592 | 产品号 | 001 | | 活性成分 | DICLOFENAC | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 18MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2013/10/18 | 申请机构 | IROKO PHARMACEUTICALS LLC
| | 化学类型 | New dosage form | 审评分类 | Standard 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 | | NP | 2016/10/18 | | I-692 | 2017/08/22 | | 历史市场独占权保护信息 | | 无 |
|
| 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 | | 204592 | 008 | AP | Letter | 2016/05/10 | 下载 | | 204592 | 008 | AP | Label | 2016/05/11 | 下载 | | 204592 | 007 | AP | Letter | 2016/05/10 | 下载 | | 204592 | 007 | AP | Label | 2016/05/11 | 下载 | | 204592 | 004 | AP | Label | 2014/08/26 | 下载 | | 204592 | 004 | AP | Letter | 2014/08/27 | 下载 | | 204592 | 002 | AP | Label | 2014/08/26 | 下载 | | 204592 | 002 | AP | Letter | 2014/08/27 | 下载 | | 204592 | 000 | AP | Letter | 2013/10/22 | 下载 | | 204592 | 000 | AP | Label | 2013/10/22 | 下载 | | 204592 | 000 | AP | Medication Guide | 2013/10/24 | 下载 | | 204592 | 000 | AP | Review | 2014/03/26 | 下载 | | 204592 | 000 | AP | Summary Review | 2014/03/26 | 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 | | 204592 | 008 | AP | 2016/05/09 | Labeling Revision | | 204592 | 007 | AP | 2016/05/09 | Labeling Revision | | 204592 | 006 | AP | 2015/01/29 | Manufacturing Change or Addition | | 204592 | 004 | AP | 2014/08/22 | Efficacy Supplement with Clinical Data to Support | | 204592 | 003 | AP | 2014/08/11 | Manufacturing Change or Addition | | 204592 | 002 | AP | 2014/08/22 | Efficacy Supplement with Clinical Data to Support | | 204592 | 001 | AP | 2014/04/14 | Manufacturing Change or Addition | | 204592 | 000 | AP | 2013/10/18 | Approval |
|