药品名称DECADRON
申请号011664产品号006
活性成分DEXAMETHASONE市场状态停止上市
剂型或给药途径TABLET;ORAL规格6MG
治疗等效代码参比药物
批准日期1982/07/30申请机构MERCK AND CO INC
化学类型New molecular entity (NME)审评分类Priority 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
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
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
011664063APLabel2016/08/02下载
011664063APLetter2016/08/02下载
011664062APLetter2004/05/27下载
011664062APLabel2004/05/27下载
011664062APReview2007/07/20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
011664063AP2016/07/29Labeling Revision
011664062AP2004/05/17Labeling Revision
011664060AP2002/06/25Manufacturing Change or Addition
011664058AP1999/02/19Control Supplement
011664057AP1998/02/26Package Change
011664055AP1998/05/14Formulation Revision
011664053AP1996/03/01Manufacturing Change or Addition
011664050AP1993/08/25Labeling Revision
011664047AP1988/05/03Manufacturing Change or Addition
011664045AP1985/11/26Labeling Revision
011664044AP1989/05/16Labeling Revision
011664043AP1983/05/11Manufacturing Change or Addition
011664042AP1983/03/22Manufacturing Change or Addition
011664041AP1984/05/03Manufacturing Change or Addition
011664038AP1981/04/01Labeling Revision
011664037AP1982/02/10Package Change
011664036AP1982/07/30Labeling Revision
011664035AP1980/04/23Formulation Revision
011664034AP1980/02/04Labeling Revision
011664033AP1980/02/04Labeling Revision
011664032AP1980/02/05Control Supplement
011664031AP1979/08/15Labeling Revision
011664030AP1979/09/24Manufacturing Change or Addition
011664029AP1979/07/26Labeling Revision
011664028AP1979/07/26Labeling Revision
011664027AP1979/07/26Labeling Revision
011664026AP1979/10/26Package Change
011664025AP1978/10/11Control Supplement
011664024AP1979/07/26Labeling Revision
011664021AP1982/07/30Control Supplement
011664000AP1958/10/30Approval