药品名称DICLEGIS
申请号021876产品号001
活性成分DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET, DELAYED RELEASE;ORAL规格10MG;10MG
治疗等效代码AB参比药物
批准日期2013/04/08申请机构DUCHESNAY INC
化学类型New formulation or new manufacturer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
63406952021/06/21YU-1382PDF格式
75601222019/01/25YPDF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
NP2016/04/08
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
021876006APLetter2014/12/17下载
021876002APLabel2013/09/30下载
021876000APReview2014/03/25下载
021876000APSummary Review2014/03/25下载
021876000APLetter2013/04/10下载
021876000APLabel2013/04/16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
021876009AP2016/03/10Manufacturing Change or Addition
021876008AP2015/09/10Manufacturing Change or Addition
021876007AP2015/06/23Manufacturing Change or Addition
021876006AP2014/12/16Labeling Revision
021876005AP2014/11/24Manufacturing Change or Addition
021876004AP2014/07/30Manufacturing Change or Addition
021876003AP2014/03/28Manufacturing Change or Addition
021876002AP2013/09/30Manufacturing Change or Addition
021876001AP2014/01/29Manufacturing Change or Addition
021876000AP2013/04/08Approval