药品名称HEXADROL
申请号014694产品号002
活性成分DEXAMETHASONE SODIUM PHOSPHATE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ORGANON USA INC
化学类型New active ingredient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
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
014694030APLabel2014/07/17下载
014694030APLetter2014/07/17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
014694030AP2014/07/16Labeling Revision
014694028AP1995/11/08Labeling Revision
014694027AP1995/08/02Manufacturing Change or Addition
014694026AP1994/02/28Manufacturing Change or Addition
014694025AP1992/03/24Manufacturing Change or Addition
014694024AP1988/03/28Labeling Revision
014694023AP1987/06/02Control Supplement
014694021AP1985/02/21Labeling Revision
014694018AP1984/01/23Manufacturing Change or Addition
014694017AP1981/04/27Manufacturing Change or Addition
014694015AP1981/04/27Control Supplement
014694000AP1964/12/04Approval