药品名称SOLU-CORTEF
申请号009866产品号003
活性成分HYDROCORTISONE SODIUM SUCCINATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格EQ 500MG BASE/VIAL
治疗等效代码AP参比药物
批准日期Approved Prior to Jan 1, 1982申请机构PHARMACIA AND UPJOHN CO
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
009866105APLetter2016/09/09下载
009866105APLabel2016/09/09下载
009866104APLetter2014/07/08下载
009866104APLabel2014/07/08下载
009866098APLetter2016/09/09下载
009866098APLabel2016/09/09下载
009866080APLetter2010/06/28下载
009866080APLabel2010/07/01下载
009866079APLabel2009/10/05下载
009866079APLetter2009/11/09下载
009866077APLabel2009/10/05下载
009866077APLetter2009/11/09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
009866108AP2016/02/25Manufacturing Change or Addition
009866105AP2016/09/08Labeling Revision
009866104AP2014/07/03Labeling Revision
009866103AP2014/06/24Manufacturing Change or Addition
009866102AP2014/06/09Manufacturing Change or Addition
009866101AP2014/07/22Manufacturing Change or Addition
009866099AP2014/03/28Manufacturing Change or Addition
009866098AP2016/09/08Labeling Revision
009866097AP2013/09/27Manufacturing Change or Addition
009866096AP2013/11/08Manufacturing Change or Addition
009866095AP2014/04/04Manufacturing Change or Addition
009866092AP2014/09/06Manufacturing Change or Addition
009866090AP2015/09/23Manufacturing Change or Addition
009866080AP2010/06/16Manufacturing Change or Addition
009866079AP2009/09/01Labeling Revision
009866077AP2009/09/01Labeling Revision
009866072AP2002/10/21Control Supplement
009866071AP2000/04/04Manufacturing Change or Addition
009866070AP1999/11/25Control Supplement
009866067AP1994/09/15Control Supplement
009866065AP1994/03/25Package Change
009866062AP1994/12/06Control Supplement
009866061AP1993/12/28Labeling Revision
009866059AP1991/04/01Control Supplement
009866057AP1990/01/16Control Supplement
009866056AP1990/03/29Control Supplement
009866055AP1988/05/13Manufacturing Change or Addition
009866054AP1987/07/02Package Change
009866052AP1987/07/23Package Change
009866051AP1985/07/24Labeling Revision
009866050AP1989/03/22Labeling Revision
009866047AP1981/12/15Labeling Revision
009866046AP1981/12/15Package Change
009866045AP1980/04/14Labeling Revision
009866044AP1979/09/24Expiration Date Change
009866043AP1979/06/18Expiration Date Change
009866000AP1955/04/27Approval