药品名称PULMICORT RESPULES
申请号020929产品号001
活性成分BUDESONIDE市场状态处方药
剂型或给药途径SUSPENSION;INHALATION规格0.25MG/2ML
治疗等效代码AN参比药物
批准日期2000/08/08申请机构ASTRAZENECA PHARMACEUTICALS LP
化学类型New dosage form审评分类Priority 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
65986032018/12/23U-529PDF格式
68990992018/12/23U-529PDF格式
75248342018/11/11YU-966PDF格式
6598603*PED2019/06/23PDF格式
6899099*PED2019/06/23PDF格式
7524834*PED2019/05/11PDF格式
历史专利信息
4787536*PED2006/08/27PDF格式
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
020929044APLabel2010/07/06下载
020929044APLetter2010/07/23下载
020929043APLabel2009/10/14下载
020929043APLetter2009/11/10下载
020929032APLetter2007/07/05下载
020929022APLetter2005/07/08下载
020929015APLabel2003/09/30下载
020929015APLetter2003/09/26下载
020929015APReview2007/04/11下载
020929013APReview2007/04/11下载
020929013APLabel2003/02/26下载
020929013APLetter2003/03/10下载
020929012APLetter2003/01/10下载
020929002APLetter2006/07/21下载
020929000APReview2004/02/11下载
020929000APLetter2000/08/08下载
020929000APLabel2000/08/08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
020929051AP2015/08/18Manufacturing Change or Addition
020929050AP2013/04/10Manufacturing Change or Addition
020929049AP2013/05/15Manufacturing Change or Addition
020929044AP2010/07/02Labeling Revision
020929043AP2009/10/05Labeling Revision
020929032AP2007/06/18Labeling Revision
020929022AP2005/06/30Efficacy Supplement with Clinical Data to Support
020929015AP2003/09/26Labeling Revision
020929013AP2003/02/26Efficacy Supplement with Clinical Data to Support
020929012AP2003/01/10Labeling Revision
020929011AP2002/07/25Manufacturing Change or Addition
020929009AP2001/09/24Control Supplement
020929008AP2001/05/16Control Supplement
020929007AP2001/05/16Control Supplement
020929006AP2001/05/16Control Supplement
020929005AP2001/06/18Control Supplement
020929004AP2001/04/25Control Supplement
020929003AP2001/07/16Control Supplement
020929002AP2006/07/21Control Supplement
020929001AP2001/02/09Control Supplement
020929000AP2000/08/08Approval