药品名称ANGIOMAX
申请号020873产品号001
活性成分BIVALIRUDIN市场状态处方药
剂型或给药途径INJECTABLE;INTRAVENOUS规格250MG/VIAL
治疗等效代码AP参比药物
批准日期2000/12/15申请机构THE MEDICINES CO
化学类型New molecular entity (NME)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
75983432028/07/27YPDF格式
75827272028/07/27YPDF格式
7582727*PED2029/01/27PDF格式
7598343*PED2029/01/27PDF格式
历史专利信息
51964042010/03/23PDF格式
51964042014/12/15YYU-1040PDF格式
51964042014/12/15YYU-1232PDF格式
5196404*PED2015/06/15PDF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
I-4582008/06/13
I-4862008/11/30
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
020873036APLetter2016/03/22下载
020873036APLabel2016/03/22下载
020873029APLabel2013/05/21下载
020873029APLetter2013/05/22下载
020873023APLetter2010/06/29下载
020873023APLabel2010/07/01下载
020873014APLetter2005/09/08下载
020873011APLabel2005/12/05下载
020873011APLetter2005/12/05下载
020873009APLetter2004/05/07下载
020873006APLetter2005/06/15下载
020873004APLetter2002/06/20下载
020873000APReview2004/04/08下载
020873000APLetter2000/12/15下载
020873000APLabel2000/12/15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
020873036AP2016/03/21Labeling Revision
020873035AP2015/09/03Manufacturing Change or Addition
020873034AP2016/03/08Manufacturing Change or Addition
020873033AP2016/05/10Manufacturing Change or Addition
020873032AP2015/05/29Manufacturing Change or Addition
020873031AP2014/08/07Manufacturing Change or Addition
020873030AP2013/07/30Manufacturing Change or Addition
020873029AP2013/05/17Labeling Revision
020873028AP2013/02/15Manufacturing Change or Addition
020873027AP2012/11/09Manufacturing Change or Addition
020873023AP2010/06/23Labeling Revision
020873014AP2005/09/02Labeling Revision
020873011AP2005/11/30New or Modified Indication
020873009AP2004/05/07Labeling Revision
020873006AP2005/06/13New or Modified Indication
020873004AP2002/06/20Labeling Revision
020873003AP2001/06/22Control Supplement
020873002AP2001/05/14Package Change
020873001AP2001/04/02Expiration Date Change
020873000AP2000/12/15Approval