药品名称TRACLEER
申请号021290产品号001
活性成分BOSENTAN市场状态处方药
剂型或给药途径TABLET;ORAL规格62.5MG
治疗等效代码参比药物
批准日期2001/11/20申请机构ACTELION PHARMACEUTICALS LTD
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
52927402015/11/20PDF格式
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
M-642010/02/15
NCE2006/11/20
ODE2008/11/20
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
021290033APLetter2016/10/21下载
021290033APLabel2016/10/21下载
021290029APLabel2015/12/08下载
021290029APLetter2015/12/09下载
021290027APLabel2015/12/08下载
021290027APLetter2015/12/09下载
021290025APLabel2013/07/03下载
021290025APLetter2013/07/05下载
021290022APMedication Guide2012/10/05下载
021290022APLabel2012/10/05下载
021290022APLetter2012/10/09下载
021290019APLabel2011/02/09下载
021290019APLetter2011/02/14下载
021290018APLetter2010/02/25下载
021290018APOther2010/03/05下载
021290016APLetter2009/08/20下载
021290016APLabel2009/09/17下载
021290015APLabel2009/03/20下载
021290015APLetter2009/03/24下载
021290014APLetter2009/02/18下载
021290014APLabel2009/02/20下载
021290012APLabel2009/08/11下载
021290012APSummary Review2009/08/11下载
021290012APLetter2009/08/13下载
021290011APLetter2007/06/04下载
021290010APLabel2007/02/21下载
021290010APLetter2007/02/23下载
021290007APLabel2005/12/05下载
021290007APLetter2005/12/06下载
021290006APLetter2005/12/06下载
021290006APLabel2005/12/05下载
021290004APLetter2004/12/02下载
021290001APLetter2003/10/06下载
021290001APLabel2003/10/10下载
021290001APReview2003/12/15下载
021290000APLetter2001/11/20下载
021290000APLabel2001/11/20下载
021290000APReview2001/11/20下载
021290000APMedication Guide2003/05/07下载
021290000APOther2013/02/04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
021290033AP2016/10/20Labeling Revision
021290031AP2016/10/07Manufacturing Change or Addition
021290029AP2015/12/04Labeling Revision
021290027AP2015/12/04Supplement
021290025AP2013/07/01Labeling Revision
021290024AP2013/06/03Manufacturing Change or Addition
021290022AP2012/10/04Efficacy Supplement with Clinical Data to Support
021290019AP2011/02/08Labeling Revision
021290018AP2010/02/19Labeling Revision
021290016AP2009/08/07Labeling Revision
021290015AP2009/03/17Labeling Revision
021290014AP2009/02/13Labeling Revision
021290012AP2009/08/07New or Modified Indication
021290011AP2007/06/01Labeling Revision
021290010AP2007/02/15Efficacy Supplement with Clinical Data to Support
021290007AP2005/11/29Labeling Revision
021290006AP2005/11/29Efficacy Supplement with Clinical Data to Support
021290004AP2004/11/24Labeling Revision
021290001AP2003/10/06Efficacy Supplement with Clinical Data to Support
021290000AP2001/11/20Approval