药品名称DORYX
申请号050795产品号005
活性成分DOXYCYCLINE HYCLATE市场状态处方药
剂型或给药途径TABLET, DELAYED RELEASE;ORAL规格EQ 200MG BASE
治疗等效代码AB参比药物
批准日期2013/04/11申请机构MAYNE PHARMA INTERNATIONAL PTY LTD
化学类型New dosage form审评分类Standard review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
69581612022/12/15YU-918PDF格式
87157242028/02/03YPDF格式
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
D-1362016/04/11
NS2016/04/11
历史市场独占权保护信息
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
050795022APLabel2016/05/23下载
050795022APLetter2016/05/24下载
050795021APLetter2016/05/20下载
050795021APLabel2016/05/20下载
050795020APLetter2015/03/06下载
050795020APLabel2015/03/12下载
050795019APReview2015/11/18下载
050795019APLabel2016/04/01下载
050795019APLetter2016/04/01下载
050795018APLetter2015/06/10下载
050795018APLabel2015/06/10下载
050795014APLabel2011/09/16下载
050795013APLetter2011/03/24下载
050795013APLabel2011/03/28下载
050795010APLetter2013/04/16下载
050795010APLabel2013/04/16下载
050795005APLetter2008/06/24下载
050795005APLabel2008/06/26下载
050795003APLabel2007/12/27下载
050795003APLetter2008/01/09下载
050795002APLabel2006/12/26下载
050795002APLetter2006/12/28下载
050795000APLetter2005/05/17下载
050795000APLabel2005/05/17下载
050795000APReview2006/04/21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
050795023AP2016/10/18Manufacturing Change or Addition
050795022AP2016/05/20Efficacy Supplement with Clinical Data to Support
050795021AP2016/05/18Labeling Revision
050795020AP2015/03/04Labeling Revision
050795019AP2014/12/19Manufacturing Change or Addition
050795018AP2015/06/04Labeling Revision
050795017AP2013/12/06Manufacturing Change or Addition
050795016AP2013/12/06Manufacturing Change or Addition
050795015AP2013/11/25Manufacturing Change or Addition
050795014AP2011/09/13Manufacturing Change or Addition
050795013AP2011/03/21Labeling Revision
050795011AP2013/04/11Manufacturing Change or Addition
050795010AP2013/04/11Efficacy Supplement with Clinical Data to Support
050795005AP2008/06/20Formulation Revision
050795003AP2007/12/18Labeling Revision
050795002AP2006/12/19Efficacy Supplement with Clinical Data to Support
050795000AP2005/05/06Approval