药品名称CLINORIL
申请号017911产品号002
活性成分SULINDAC市场状态停止上市
剂型或给药途径TABLET;ORAL规格200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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Approved Prior to Jan 1, 1982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
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
017911074APLabel2010/12/26下载
017911074APLetter2010/12/28下载
017911073APLabel2010/06/07下载
017911073APLetter2010/06/10下载
017911072APLetter2009/04/03下载
017911072APLabel2009/04/03下载
017911070APLabel2007/08/27下载
017911070APLetter2007/08/27下载
017911068APLabel2006/01/25下载
017911068APLetter2006/01/30下载
017911065APLabel2006/10/11下载
017911065APLetter2006/10/13下载
017911000APMedication Guide2009/11/16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
017911074AP2010/12/23Labeling Revision
017911073AP2010/06/04Labeling Revision
017911072AP2009/03/30Labeling Revision
017911070AP2007/08/23Labeling Revision
017911068AP2006/01/24Labeling Revision
017911067AP2001/02/07Control Supplement
017911066AP2001/10/30Labeling Revision
017911065AP2006/10/05Labeling Revision
017911064AP1997/04/14Control Supplement
017911063AP1997/05/02Control Supplement
017911062AP1996/03/01Manufacturing Change or Addition
017911060AP1994/10/24Control Supplement
017911059AP1994/08/18Control Supplement
017911058AP1995/07/10Labeling Revision
017911057AP1995/06/01Labeling Revision
017911055AP1992/07/27Control Supplement
017911052AP1989/05/31Labeling Revision
017911051AP1989/05/31Labeling Revision
017911050AP1989/01/09Labeling Revision
017911049AP1989/02/06Control Supplement
017911047AP1989/01/09Labeling Revision
017911046AP1989/01/09Labeling Revision
017911045AP1988/05/03Manufacturing Change or Addition
017911044AP1989/01/09Labeling Revision
017911043AP1989/01/09Labeling Revision
017911040AP1989/01/09Labeling Revision
017911038AP1986/02/05Labeling Revision
017911037AP1986/02/05Labeling Revision
017911035AP1986/02/05Labeling Revision
017911034AP1984/11/26Labeling Revision
017911033AP1984/07/26Manufacturing Change or Addition
017911031AP1984/01/26Labeling Revision
017911027AP1989/05/31Labeling Revision
017911025AP1984/08/13Control Supplement
017911023AP1984/05/29Control Supplement
017911022AP1983/06/29Control Supplement
017911020AP1982/06/22Labeling Revision
017911018AP1982/06/22Labeling Revision
017911017AP1982/06/29Labeling Revision
017911016AP1984/11/20Manufacturing Change or Addition
017911015AP1993/05/12Formulation Revision
017911014AP1981/04/27Package Change
017911013AP1981/06/05Manufacturing Change or Addition
017911011AP1981/12/21Package Change
017911009AP1981/12/14Labeling Revision
017911008AP1981/12/14Package Change
017911007AP1979/08/08Control Supplement
017911006AP1979/10/01Control Supplement
017911005AP1981/05/12Labeling Revision
017911004AP1979/08/06Labeling Revision
017911003AP1979/08/08Labeling Revision
017911002AP1979/07/23Manufacturing Change or Addition
017911001AP1979/08/14Expiration Date Change
017911000AP1978/09/27Approval