药品名称 | QNASL | 申请号 | 202813 | 产品号 | 002 | 活性成分 | BECLOMETHASONE DIPROPIONATE | 市场状态 | 处方药 | 剂型或给药途径 | AEROSOL, METERED;NASAL | 规格 | 0.04MG/ACTUATION | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 2014/12/17 | 申请机构 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
| 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 | NS | 2017/12/17 | 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 | 202813 | 009 | AP | Letter | 2014/12/18 | 下载 | 202813 | 009 | AP | Label | 2014/12/19 | 下载 | 202813 | 007 | AP | Letter | 2014/12/18 | 下载 | 202813 | 007 | AP | Label | 2014/12/19 | 下载 | 202813 | 006 | AP | Letter | 2014/07/11 | 下载 | 202813 | 005 | AP | Label | 2014/03/20 | 下载 | 202813 | 005 | AP | Letter | 2014/03/20 | 下载 | 202813 | 000 | AP | Letter | 2012/03/27 | 下载 | 202813 | 000 | AP | Label | 2012/03/27 | 下载 | 202813 | 000 | AP | Review | 2013/06/10 | 下载 | 202813 | 000 | AP | Summary Review | 2013/06/10 | 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 | 202813 | 010 | AP | 2016/02/29 | Manufacturing Change or Addition | 202813 | 009 | AP | 2014/12/17 | Efficacy Supplement with Clinical Data to Support | 202813 | 008 | AP | 2015/02/03 | Manufacturing Change or Addition | 202813 | 007 | AP | 2014/12/17 | Efficacy Supplement with Clinical Data to Support | 202813 | 006 | AP | 2014/07/10 | Labeling Revision | 202813 | 005 | AP | 2014/03/19 | Labeling Revision | 202813 | 004 | AP | 2015/03/09 | Manufacturing Change or Addition | 202813 | 003 | AP | 2013/08/29 | Manufacturing Change or Addition | 202813 | 000 | AP | 2012/03/23 | Approval |
|