药品名称TRANXENE SD
申请号017105产品号004
活性成分CLORAZEPATE DIPOTASSIUM市场状态停止上市
剂型或给药途径TABLET;ORAL规格22.5MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构RECORDATI RARE DISEASES 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
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
017105077APLetter2011/07/21下载
017105076APLabel2010/06/14下载
017105076APLetter2010/06/15下载
017105076APMedication Guide2010/06/24下载
017105075APLabel2009/04/28下载
017105075APLetter2009/04/29下载
017105070APLetter2003/03/26下载
017105070APReview2006/10/25下载
017105062APReview2007/07/09下载
017105062APLetter2002/02/07下载
017105059APLetter2002/02/07下载
017105059APReview2007/07/09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
017105078AP2015/02/03Manufacturing Change or Addition
017105077AP2011/07/19Labeling Revision
017105076AP2010/06/07Labeling Revision
017105075AP2009/04/23Labeling Revision
017105070AP2003/03/13Labeling Revision
017105069AP2002/08/28Control Supplement
017105068AP1998/05/08Package Change
017105067AP1999/08/04Control Supplement
017105066AP1996/11/05Control Supplement
017105064AP1988/11/08Control Supplement
017105062AP2002/02/07Labeling Revision
017105060AP1987/11/05Package Change
017105059AP2002/02/07Labeling Revision
017105058AP1987/08/13Control Supplement
017105057AP1987/01/08Control Supplement
017105056AP1986/11/14Control Supplement
017105055AP1986/08/29Control Supplement
017105054AP1985/08/26Control Supplement
017105053AP1986/06/16Control Supplement
017105052AP1984/02/27Control Supplement
017105045AP1980/10/28Control Supplement
017105044AP1980/09/08Formulation Revision
017105043AP1980/07/14Labeling Revision
017105040AP1979/12/12Labeling Revision
017105039AP1981/01/29General Efficacy (MarkIV)
017105038AP1979/05/31Control Supplement
017105037AP1979/06/05Formulation Revision
017105036AP1979/06/07Manufacturing Change or Addition
017105035AP1979/06/07Control Supplement
017105034AP1979/06/07Control Supplement
017105033AP1978/12/06Package Change
017105032AP1978/04/17Formulation Revision
017105031AP1978/05/05Formulation Revision
017105030AP1977/10/21Labeling Revision
017105029AP1979/07/09Control Supplement
017105028AP1977/10/20Formulation Revision
017105025AP1976/12/21Manufacturing Change or Addition
017105024AP1977/01/04Manufacturing Change or Addition
017105023AP1976/12/21Manufacturing Change or Addition
017105022AP1980/03/10Manufacturing Change or Addition
017105021AP1976/05/07Formulation Revision
017105019AP1977/03/18Control Supplement
017105017AP1976/07/30Control Supplement
017105016AP1976/08/04Labeling Revision
017105015AP1976/08/04Control Supplement
017105014AP1975/09/10Control Supplement
017105013AP1975/11/05Labeling Revision
017105009AP1975/11/13Control Supplement
017105008AP1975/03/31Control Supplement
017105000AP1972/06/23Approval