药品名称CUROSURF
申请号020744产品号001
活性成分PORACTANT ALFA市场状态处方药
剂型或给药途径SUSPENSION;INTRATRACHEAL规格80MG/ML
治疗等效代码参比药物
批准日期1999/11/18申请机构CHIESI USA 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
020744028APLetter2014/10/15下载
020744028APLabel2014/10/15下载
020744019APLetter2008/10/01下载
020744019APLabel2008/10/03下载
020744004APLetter2002/03/01下载
020744002APLetter2004/03/03下载
020744000APReview2001/07/02下载
020744000APLetter1999/11/18下载
020744000APLabel1999/11/18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
020744030AP2015/05/04Manufacturing Change or Addition
020744029AP2014/10/15Manufacturing Change or Addition
020744028AP2014/10/10Labeling Revision
020744027AP2014/02/12Manufacturing Change or Addition
020744026AP2013/04/15Manufacturing Change or Addition
020744025AP2013/04/15Manufacturing Change or Addition
020744019AP2008/09/26Labeling Revision
020744009AP2002/12/13Manufacturing Change or Addition
020744008AP2002/04/17Control Supplement
020744006AP2002/06/03Manufacturing Change or Addition
020744005AP2002/04/05Control Supplement
020744004AP2002/03/01Efficacy Supplement with Clinical Data to Support
020744003AP2002/11/21Control Supplement
020744002AP2004/02/17Control Supplement
020744001AP2001/06/19Control Supplement
020744000AP1999/11/18Approval