| 药品名称 | ZOMIG | | 申请号 | 020768 | 产品号 | 002 | | 活性成分 | ZOLMITRIPTAN | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 5MG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 1997/11/25 | 申请机构 | IPR PHARMACEUTICALS INC
| | 化学类型 | New molecular entity (NME) | 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 | | 无 | | 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 | | 020768 | 021 | AP | Letter | 2012/09/18 | 下载 | | 020768 | 021 | AP | Label | 2012/09/18 | 下载 | | 020768 | 019 | AP | Label | 2012/09/18 | 下载 | | 020768 | 019 | AP | Letter | 2012/09/18 | 下载 | | 020768 | 017 | AP | Letter | 2010/08/16 | 下载 | | 020768 | 017 | AP | Label | 2010/08/19 | 下载 | | 020768 | 013 | AP | Letter | 2004/01/14 | 下载 | | 020768 | 012 | AP | Letter | 2004/11/19 | 下载 | | 020768 | 012 | AP | Label | 2004/11/19 | 下载 | | 020768 | 011 | AP | Letter | 2003/06/08 | 下载 | | 020768 | 010 | AP | Letter | 2002/10/09 | 下载 | | 020768 | 010 | AP | Review | 2008/02/19 | 下载 | | 020768 | 006 | AP | Letter | 2002/01/29 | 下载 | | 020768 | 000 | AP | Review | 2010/01/29 | 下载 | | 020768 | 000 | AP | Other Important Information from FDA | 2007/01/17 | 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 | | 020768 | 022 | AP | 2014/03/12 | Manufacturing Change or Addition | | 020768 | 021 | AP | 2012/09/14 | Labeling Revision | | 020768 | 019 | AP | 2012/09/14 | Labeling Revision | | 020768 | 017 | AP | 2010/08/11 | Labeling Revision | | 020768 | 013 | AP | 2004/01/08 | Labeling Revision | | 020768 | 012 | AP | 2004/11/16 | Patient Population Altered | | 020768 | 011 | AP | 2003/05/21 | Labeling Revision | | 020768 | 010 | AP | 2002/10/09 | Labeling Revision | | 020768 | 009 | AP | 2000/12/18 | Manufacturing Change or Addition | | 020768 | 008 | AP | 2000/09/12 | Manufacturing Change or Addition | | 020768 | 007 | AP | 2000/03/09 | Manufacturing Change or Addition | | 020768 | 006 | AP | 2002/01/29 | Labeling Revision | | 020768 | 005 | AP | 2000/02/14 | Manufacturing Change or Addition | | 020768 | 004 | AP | 1999/11/29 | Manufacturing Change or Addition | | 020768 | 003 | AP | 2000/05/01 | Labeling Revision | | 020768 | 002 | AP | 1999/02/16 | Control Supplement | | 020768 | 001 | AP | 1998/07/21 | Manufacturing Change or Addition | | 020768 | 000 | AP | 1997/11/25 | Approval |
|