药品名称SURVANTA
申请号020032产品号001
活性成分BERACTANT市场状态处方药
剂型或给药途径SUSPENSION;INTRATRACHEAL规格25MG/ML
治疗等效代码参比药物
批准日期1991/07/01申请机构ABBVIE INC
化学类型New molecular entity (NME)审评分类Standard review drug
罕用药/孤儿药
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
020032036APLetter2009/01/14下载
020032035APLetter2009/02/13下载
020032026APLetter2005/05/02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
020032044AP2014/12/03Manufacturing Change or Addition
020032043AP2016/02/25Manufacturing Change or Addition
020032042AP2013/06/12Manufacturing Change or Addition
020032041AP2013/04/10Manufacturing Change or Addition
020032036AP2009/01/12Labeling Revision
020032035AP2009/02/10Labeling Revision
020032026AP2005/04/28Manufacturing Change or Addition
020032023AP2002/12/06Control Supplement
020032020AP2002/04/30Manufacturing Change or Addition
020032019AP2001/03/23Control Supplement
020032018AP2000/11/27Control Supplement
020032017AP2000/08/25Control Supplement
020032015AP2000/12/12Manufacturing Change or Addition
020032014AP2000/02/24Manufacturing Change or Addition
020032013AP1999/10/14Control Supplement
020032012AP1999/06/16Control Supplement
020032011AP1999/10/20Control Supplement
020032010AP1998/12/09Control Supplement
020032009AP1996/04/04Control Supplement
020032008AP1994/09/27Control Supplement
020032007AP1994/09/06Manufacturing Change or Addition
020032006AP1994/08/29Control Supplement
020032005AP1994/07/28Package Change
020032004AP1995/03/10Labeling Revision
020032003AP1992/09/09Control Supplement
020032002AP1994/03/24Manufacturing Change or Addition
020032001AP1992/08/17Control Supplement
020032000AP1991/07/01Approval