药品名称PRINIVIL
申请号019558产品号006
活性成分LISINOPRIL市场状态停止上市
剂型或给药途径TABLET;ORAL规格2.5MG
治疗等效代码参比药物
批准日期1994/01/28申请机构MERCK RESEARCH LABORATORIES DIV MERCK CO 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
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
PED2006/11/29
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
019558060APLabel2016/10/17下载
019558060APLetter2016/10/19下载
019558059APLetter2015/09/01下载
019558059APLabel2015/09/03下载
019558057APLetter2015/07/13下载
019558057APLabel2015/07/13下载
019558056APLetter2013/02/28下载
019558056APLabel2013/03/01下载
019558055APLetter2012/06/08下载
019558055APLabel2012/06/11下载
019558054APLetter2011/11/21下载
019558054APLabel2011/11/21下载
019558053APLetter2011/06/17下载
019558052APLetter2008/10/14下载
019558051APLetter2008/10/14下载
019558050APLetter2007/02/12下载
019558049APLetter2006/10/23下载
019558047APLetter2006/06/20下载
019558046APLetter2005/10/11下载
019558044APLetter2004/03/03下载
019558043APLetter2003/06/08下载
019558043APLabel2003/06/08下载
019558043APReview2005/04/17下载
019558040APLetter2004/05/07下载
019558036APReview2001/06/22下载
019558000APLetter2004/06/14下载
019558000APLabel2004/06/14下载
019558000APOther 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
019558060AP2016/10/14Labeling Revision
019558059AP2015/08/28Labeling Revision
019558058AP2014/08/22Manufacturing Change or Addition
019558057AP2015/07/08Labeling Revision
019558056AP2013/02/26Labeling Revision
019558055AP2012/06/06Labeling Revision
019558054AP2011/11/17Labeling Revision
019558053AP2011/06/10Labeling Revision
019558052AP2008/10/09Labeling Revision
019558051AP2008/10/09Labeling Revision
019558050AP2007/02/02Labeling Revision
019558049AP2006/10/18Labeling Revision
019558047AP2006/06/16Labeling Revision
019558046AP2005/10/05Labeling Revision
019558044AP2004/03/02Labeling Revision
019558043AP2003/05/29Patient Population Altered
019558042AP2001/08/23Manufacturing Change or Addition
019558041AP2001/04/26Manufacturing Change or Addition
019558040AP2004/05/05Labeling Revision
019558039AP2000/06/09Manufacturing Change or Addition
019558038AP2001/08/07Labeling Revision
019558037AP1999/03/15Manufacturing Change or Addition
019558036AP1999/02/17Labeling Revision
019558035AP1996/09/03Labeling Revision
019558034AP1995/11/01Control Supplement
019558033AP1995/09/28Labeling Revision
019558032AP1995/06/26Control Supplement
019558031AP1995/09/28Labeling Revision
019558030AP1995/06/08Manufacturing Change or Addition
019558029AP1995/03/21Control Supplement
019558028AP1995/02/22Labeling Revision
019558027AP1995/11/24New or Modified Indication
019558026AP1994/07/24Labeling Revision
019558025AP1994/03/10Labeling Revision
019558024AP1993/09/23Labeling Revision
019558023AP1994/01/28Formulation Revision
019558022AP1994/05/11Labeling Revision
019558021AP1994/01/14Labeling Revision
019558020AP1993/03/10Labeling Revision
019558019AP1996/09/03Labeling Revision
019558018AP1992/09/30Labeling Revision
019558017AP1992/05/13Labeling Revision
019558016AP1992/05/07Labeling Revision
019558015AP1992/01/23Package Change
019558014AP1992/09/30Package Change
019558012AP1991/09/09Control Supplement
019558011AP1991/03/28Labeling Revision
019558010AP1991/02/06Labeling Revision
019558009AP1991/01/07Control Supplement
019558008AP1990/04/11Labeling Revision
019558007AP1993/06/14New or Modified Indication
019558006AP1989/08/09Labeling Revision
019558005AP1989/01/31Labeling Revision
019558004AP1989/03/29Labeling Revision
019558003AP1988/08/19Control Supplement
019558002AP1988/10/25Labeling Revision
019558001AP1988/10/25Labeling Revision
019558000AP1987/12/29Approval