药品名称DANTRIUM
申请号017443产品号001
活性成分DANTROLENE SODIUM市场状态处方药
剂型或给药途径CAPSULE;ORAL规格25MG
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构PAR STERILE PRODUCTS LLC
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
017443049APLetter2012/07/18下载
017443049APLabel2012/07/19下载
017443048APLabel2012/07/19下载
017443048APLetter2012/07/18下载
017443046APLabel2012/07/19下载
017443046APLetter2012/07/18下载
017443043APLetter2012/07/18下载
017443043APLabel2012/07/19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
017443065AP2015/07/08Manufacturing Change or Addition
017443064AP2014/03/11Manufacturing Change or Addition
017443049AP2012/07/17Labeling Revision
017443048AP2012/07/17Labeling Revision
017443047AP1997/10/30Control Supplement
017443046AP2012/07/17Labeling Revision
017443045AP1997/03/14Control Supplement
017443044AP1996/09/18Manufacturing Change or Addition
017443043AP2012/07/17Labeling Revision
017443041AP1992/01/24Package Change
017443040AP1991/05/20Control Supplement
017443039AP1990/02/14Package Change
017443038AP1989/06/29Package Change
017443036AP1985/07/23Labeling Revision
017443035AP1985/05/20Control Supplement
017443033AP1983/05/16Control Supplement
017443032AP1983/05/16Control Supplement
017443031AP1983/05/16Control Supplement
017443030AP1983/05/16Control Supplement
017443029AP1983/05/16Control Supplement
017443028AP1983/11/18Manufacturing Change or Addition
017443025AP1982/09/29Labeling Revision
017443024AP1981/10/09Labeling Revision
017443023AP1981/03/18Formulation Revision
017443022AP1979/09/17Package Change
017443021AP1979/08/15Package Change
017443020AP1979/08/15Package Change
017443019AP1979/07/05Manufacturing Change or Addition
017443017AP1977/06/27Formulation Revision
017443016AP1977/10/25Labeling Revision
017443015AP1977/06/15Labeling Revision
017443013AP1977/06/15Formulation Revision
017443012AP1976/05/12Expiration Date Change
017443011AP1976/07/16Manufacturing Change or Addition
017443010AP1976/05/12Package Change
017443009AP1975/10/10Labeling Revision
017443008AP1975/07/15Labeling Revision
017443007AP1975/11/20Control Supplement
017443006AP1975/11/19Labeling Revision
017443002AP1975/02/26Control Supplement
017443000AP1974/01/15Approval