药品名称LOPRESSOR HCT
申请号018303产品号003
活性成分HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格50MG;100MG
治疗等效代码参比药物
批准日期1984/12/31申请机构US PHARMACEUTICALS HOLDINGS I LLC
化学类型New combination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
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
018303036APLabel2011/03/21下载
018303035APLabel2011/03/21下载
018303034APLabel2009/09/17下载
018303034APLetter2010/01/06下载
018303033APLabel2008/07/29下载
018303033APLetter2008/08/13下载
018303032APLabel2008/01/08下载
018303032APLetter2008/01/09下载
018303029APLetter2006/09/18下载
018303025APLetter2003/11/25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
018303036AP2011/03/15Labeling Revision
018303035AP2011/03/15Labeling Revision
018303034AP2009/08/07Labeling Revision
018303033AP2008/07/24Labeling Revision
018303032AP2008/01/08Labeling Revision
018303029AP2006/09/07Labeling Revision
018303025AP2003/10/31Labeling Revision
018303024AP2002/06/14Control Supplement
018303023AP2002/04/29Manufacturing Change or Addition
018303022AP2002/02/08Package Change
018303021AP2001/07/30Manufacturing Change or Addition
018303020AP2000/05/10Manufacturing Change or Addition
018303019AP2000/05/12Control Supplement
018303018AP1999/04/28Package Change
018303017AP1999/02/18Manufacturing Change or Addition
018303016AP1997/11/07Labeling Revision
018303015AP1997/01/08Control Supplement
018303014AP1996/06/07Control Supplement
018303013AP1996/03/04Manufacturing Change or Addition
018303012AP1995/07/31Control Supplement
018303011AP1995/02/02Labeling Revision
018303010AP1991/11/08Formulation Revision
018303009AP1991/09/18Labeling Revision
018303008AP1990/06/14Labeling Revision
018303006AP1988/12/09Formulation Revision
018303005AP1988/09/23Labeling Revision
018303004AP1988/05/31Package Change
018303003AP1985/10/23Package Change
018303002AP1985/02/22Labeling Revision
018303001AP1985/03/26Package Change
018303000AP1984/12/31Approval