药品名称PRINZIDE
申请号019778产品号002
活性成分HYDROCHLOROTHIAZIDE; LISINOPRIL市场状态停止上市
剂型或给药途径TABLET;ORAL规格25MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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1989/02/16申请机构MERCK RESEARCH LABORATORIES DIV MERCK CO INC
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
019778049APLetter2013/02/28下载
019778049APLabel2013/03/01下载
019778048APLetter2012/06/08下载
019778048APLabel2012/06/11下载
019778047APLabel2011/08/30下载
019778047APLetter2011/08/31下载
019778046APLetter2011/11/21下载
019778046APLabel2011/11/21下载
019778045APLabel2011/02/11下载
019778044APLetter2011/06/17下载
019778043APLetter2008/10/14下载
019778042APLetter2008/10/14下载
019778040APLetter2007/02/12下载
019778039APLetter2006/10/23下载
019778037APLetter2006/06/20下载
019778036APLetter2005/10/11下载
019778035APLetter2004/03/03下载
019778034APReview2004/04/21下载
019778034APLetter2002/07/02下载
019778032APLetter2002/11/08下载
019778029APReview2001/06/22下载
019778028APReview1998/10/28下载
019778028APLetter1998/10/28下载
019778028APLabel1998/10/28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
019778049AP2013/02/26Labeling Revision
019778048AP2012/06/06Labeling Revision
019778047AP2011/08/26Labeling Revision
019778046AP2011/11/17Labeling Revision
019778045AP2011/01/28Labeling Revision
019778044AP2011/06/10Labeling Revision
019778043AP2008/10/09Labeling Revision
019778042AP2008/10/09Labeling Revision
019778040AP2007/02/02Labeling Revision
019778039AP2006/10/18Labeling Revision
019778037AP2006/06/16Labeling Revision
019778036AP2005/10/05Labeling Revision
019778035AP2004/03/02Labeling Revision
019778034AP2002/07/02Manufacturing Change or Addition
019778033AP2001/08/23Manufacturing Change or Addition
019778032AP2002/11/08Labeling Revision
019778031AP2000/06/09Manufacturing Change or Addition
019778030AP2001/08/07Labeling Revision
019778029AP1999/02/17Labeling Revision
019778028AP1998/10/28Labeling Revision
019778027AP1995/11/01Control Supplement
019778026AP1995/09/28Labeling Revision
019778025AP1995/09/28Labeling Revision
019778024AP1995/06/08Manufacturing Change or Addition
019778023AP1995/03/21Control Supplement
019778022AP1995/02/22Labeling Revision
019778021AP1995/05/30Labeling Revision
019778019AP1994/07/24Labeling Revision
019778018AP1994/03/10Labeling Revision
019778017AP1993/09/23Labeling Revision
019778016AP1994/05/11Labeling Revision
019778015AP1994/01/14Labeling Revision
019778014AP1993/11/18New Dosage Regimen
019778013AP1993/03/10Labeling Revision
019778012AP1996/09/03Labeling Revision
019778011AP1992/09/30Labeling Revision
019778010AP1992/05/13Labeling Revision
019778009AP1992/05/07Labeling Revision
019778008AP1992/01/23Package Change
019778007AP1992/09/30Package Change
019778005AP1991/03/28Labeling Revision
019778004AP1991/02/06Labeling Revision
019778003AP1990/04/12Labeling Revision
019778002AP1989/10/30Manufacturing Change or Addition
019778001AP1989/08/09Labeling Revision
019778000AP1989/02/16Approval