药品名称ANADROL-50
申请号016848产品号001
活性成分OXYMETHOLONE市场状态处方药
剂型或给药途径TABLET;ORAL规格50MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构MEDA PHARMACEUTICALS 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
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
016848021APLetter2004/08/31下载
016848021APLabel2004/08/31下载
016848020APLetter2003/11/25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
016848023AP2014/02/06Manufacturing Change or Addition
016848021AP2004/08/25Labeling Revision
016848020AP2003/11/17Labeling Revision
016848019AP2002/02/06Manufacturing Change or Addition
016848018AP1997/05/14Control Supplement
016848017AP1994/06/09Control Supplement
016848016AP1993/07/15Labeling Revision
016848015AP1992/02/18Labeling Revision
016848014AP1992/08/24Control Supplement
016848013AP1993/07/15Labeling Revision
016848012AP1991/08/14Labeling Revision
016848011AP1990/01/26Control Supplement
016848010AP1986/08/25Labeling Revision
016848009AP1983/01/18Control Supplement
016848006AP1980/04/15Labeling Revision
016848005AP1976/06/15Package Change
016848004AP1975/10/10Control Supplement
016848000AP1972/01/18Approval