药品名称MEVACOR
申请号019643产品号004
活性成分LOVASTATIN市场状态停止上市
剂型或给药途径TABLET;ORAL规格40MG **Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1988/12/14申请机构MERCK RESEARCH LABORATORIES DIV MERCK CO INC
化学类型New molecular entity (NME)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
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
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
019643088APLetter2014/02/28下载
019643088APLabel2014/03/04下载
019643087APLetter2012/11/05下载
019643087APLabel2012/11/06下载
019643086APLabel2012/11/06下载
019643086APLetter2012/11/05下载
019643085APLabel2012/02/28下载
019643085APOther2012/02/28下载
019643085APLetter2012/02/28下载
019643085APReview2012/03/30下载
019643084APLabel2011/02/04下载
019643084APLetter2011/02/07下载
019643082APLetter2011/06/17下载
019643081APLetter2010/07/02下载
019643081APLabel2010/07/06下载
019643080APLetter2009/03/11下载
019643080APLabel2009/03/17下载
019643079APLetter2008/01/09下载
019643078APLetter2007/06/04下载
019643078APLabel2007/06/04下载
019643077APLetter2005/06/14下载
019643077APLabel2005/06/14下载
019643076APLabel2005/11/08下载
019643076APLetter2005/11/18下载
019643075APLetter2005/04/12下载
019643075APLabel2005/04/12下载
019643073APReview2007/07/06下载
019643071APLetter2002/09/20下载
019643071APLabel2002/09/20下载
019643069APLabel2003/04/17下载
019643067APLetter2002/02/14下载
019643067APLabel2002/02/14下载
019643064APReview2001/08/17下载
019643064APLabel2003/04/16下载
019643062APReview2001/08/17下载
019643061APLabel2007/04/20下载
019643061APLetter2007/04/25下载
019643055APLetter1999/03/11下载
019643055APReview2000/05/17下载
019643053APReview1997/06/25下载
019643051APReview1997/06/25下载
019643050APReview1997/08/12下载
019643017APReview2007/07/06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
019643088AP2014/02/27Labeling Revision
019643087AP2012/10/31Labeling Revision
019643086AP2012/10/31Labeling Revision
019643085AP2012/02/28Labeling Revision
019643084AP2011/02/02Labeling Revision
019643082AP2011/06/10Labeling Revision
019643081AP2010/06/30Labeling Revision
019643080AP2009/03/09Control Supplement
019643079AP2007/12/07Manufacturing Change or Addition
019643078AP2007/05/29Labeling Revision
019643077AP2005/06/13Labeling Revision
019643076AP2005/11/04Labeling Revision
019643075AP2005/04/07Efficacy Supplement with Clinical Data to Support
019643073AP2003/10/17Supplement
019643071AP2002/09/20Labeling Revision
019643070AP2002/09/23Manufacturing Change or Addition
019643069AP2001/10/22Labeling Revision
019643068AP2002/01/30Control Supplement
019643067AP2002/02/14Patient Population Altered
019643066AP2001/06/26Manufacturing Change or Addition
019643065AP2001/08/01Control Supplement
019643064AP2001/04/26Labeling Revision
019643062AP2001/04/26Labeling Revision
019643061AP2007/04/17Labeling Revision
019643060AP2000/09/14Manufacturing Change or Addition
019643059AP2000/08/22Labeling Revision
019643057AP1999/03/01Labeling Revision
019643056AP1998/08/28Labeling Revision
019643055AP1999/03/11New or Modified Indication
019643054AP1998/06/29Labeling Revision
019643053AP1998/04/22Labeling Revision
019643052AP1997/11/20Package Change
019643051AP1997/06/25Control Supplement
019643050AP1997/08/12Labeling Revision
019643048AP1997/03/27Manufacturing Change or Addition
019643047AP1997/02/06Labeling Revision
019643046AP1996/12/26Control Supplement
019643045AP1996/04/30Control Supplement
019643044AP1995/08/08Labeling Revision
019643043AP1995/08/08Control Supplement
019643042AP1995/05/03New Dosage Regimen
019643041AP1995/01/23Labeling Revision
019643040AP1996/02/09Labeling Revision
019643039AP1995/08/01Manufacturing Change or Addition
019643037AP1994/12/21Labeling Revision
019643036AP1994/07/05Labeling Revision
019643035AP1994/12/20Control Supplement
019643034AP1995/02/08New or Modified Indication
019643033AP1994/05/17Labeling Revision
019643032AP1994/05/17Labeling Revision
019643031AP1993/08/09Package Change
019643030AP1992/11/27Labeling Revision
019643028AP1993/11/23Labeling Revision
019643027AP1993/11/24Labeling Revision
019643025AP1992/12/17Package Change
019643024AP1992/04/15Control Supplement
019643023AP1991/11/27Formulation Revision
019643021AP1993/11/22Labeling Revision
019643020AP1991/10/24Labeling Revision
019643018AP1991/03/28New Dosage Regimen
019643017AP1991/12/19Labeling Revision
019643015AP1991/04/10Labeling Revision
019643013AP1991/03/12Control Supplement
019643012AP1991/08/28Labeling Revision
019643011AP1989/10/20Labeling Revision
019643010AP1991/02/21Labeling Revision
019643009AP1988/12/14Labeling Revision
019643008AP1988/12/20Labeling Revision
019643007AP1989/03/21Labeling Revision
019643005AP1988/11/22Package Change
019643004AP1988/03/03Labeling Revision
019643003AP1988/07/06Manufacturing Change or Addition
019643001AP1988/03/01Labeling Revision
019643000AP1987/08/31Approval