药品名称ALTACE
申请号019901产品号001
活性成分RAMIPRIL市场状态处方药
剂型或给药途径CAPSULE;ORAL规格1.25MG
治疗等效代码AB参比药物
批准日期1991/01/28申请机构KING PHARMACEUTICALS INC
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
73684692020/08/30U-871PDF格式
历史专利信息
50617222008/10/29PDF格式
54038562012/04/04U-71PDF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
019901065APLetter2015/09/14下载
019901065APLabel2015/09/14下载
019901064APLetter2014/05/06下载
019901064APLabel2014/05/06下载
019901063APLetter2013/10/28下载
019901063APLabel2013/10/31下载
019901062APLabel2013/11/04下载
019901062APLetter2013/11/06下载
019901060APLabel2013/09/23下载
019901060APLetter2013/09/24下载
019901059APLetter2012/04/16下载
019901059APLabel2012/04/20下载
019901058APLetter2011/08/26下载
019901058APLabel2011/09/02下载
019901055APLetter2010/10/25下载
019901055APLabel2010/10/25下载
019901054APLetter2009/02/18下载
019901052APLetter2009/03/06下载
019901046APReview2011/02/15下载
019901046APLetter2004/11/16下载
019901043APLetter2004/10/22下载
019901041APLetter2004/10/22下载
019901040APLetter2004/10/22下载
019901035APLetter2002/07/10下载
019901034APLetter2002/08/02下载
019901028APReview2005/04/15下载
019901025APReview1998/12/16下载
019901000APOther Important Information from FDA2006/06/09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
019901065AP2015/09/11Labeling Revision
019901064AP2014/05/02Labeling Revision
019901063AP2013/10/25Labeling Revision
019901062AP2013/11/04Labeling Revision
019901060AP2013/09/23Labeling Revision
019901059AP2012/04/11Labeling Revision
019901058AP2011/08/23Labeling Revision
019901055AP2010/10/21Labeling Revision
019901054AP2009/02/09Labeling Revision
019901052AP2009/03/04Labeling Revision
019901046AP2004/11/15Labeling Revision
019901043AP2004/10/15Labeling Revision
019901041AP2004/10/15Labeling Revision
019901040AP2004/10/15Labeling Revision
019901035AP2002/07/10Manufacturing Change or Addition
019901034AP2002/08/02Labeling Revision
019901033AP2001/07/26Manufacturing Change or Addition
019901032AP2001/03/28Manufacturing Change or Addition
019901031AP2000/12/19Manufacturing Change or Addition
019901030AP2001/05/25Control Supplement
019901029AP2000/09/21Manufacturing Change or Addition
019901028AP2000/10/04New or Modified Indication
019901027AP2000/03/16Manufacturing Change or Addition
019901026AP2000/02/29Manufacturing Change or Addition
019901025AP1998/12/16Labeling Revision
019901024AP1998/09/24Package Change
019901023AP1998/09/22Package Change
019901022AP1998/02/25Manufacturing Change or Addition
019901021AP1997/12/04Manufacturing Change or Addition
019901020AP1997/11/25Manufacturing Change or Addition
019901019AP1996/09/03Labeling Revision
019901018AP1996/03/13Control Supplement
019901017AP1995/09/27Control Supplement
019901016AP1996/01/29Package Change
019901015AP1995/05/05Control Supplement
019901014AP1995/07/13Labeling Revision
019901013AP1995/07/13Labeling Revision
019901012AP1995/08/22Control Supplement
019901011AP1994/10/21Labeling Revision
019901010AP1995/08/22New or Modified Indication
019901009AP1995/03/01Labeling Revision
019901008AP1994/01/14Labeling Revision
019901007AP1993/05/20Package Change
019901006AP1993/01/08Labeling Revision
019901005AP1992/06/25Labeling Revision
019901004AP1992/05/18Control Supplement
019901003AP1992/01/09Package Change
019901002AP1991/05/20Control Supplement
019901001AP1991/05/20Control Supplement
019901000AP1991/01/28Approval