药品名称ARALEN
申请号006002产品号001
活性成分CHLOROQUINE PHOSPHATE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 300MG BASE
治疗等效代码AA参比药物
批准日期Approved Prior to Jan 1, 1982申请机构SANOFI AVENTIS US LLC
化学类型审评分类
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
006002043APLabel2013/11/08下载
006002043APLetter2013/11/08下载
006002042APLetter2009/06/17下载
006002039APLetter2003/06/22下载
006002039APLabel2003/06/22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
006002043AP2013/11/06Labeling Revision
006002042AP2009/06/12Labeling Revision
006002040AP2002/04/30Control Supplement
006002039AP2003/06/13Labeling Revision
006002038AP2001/05/09Control Supplement
006002037AP1995/10/11Control Supplement
006002035AP1992/06/23Formulation Revision
006002034AP1992/03/11Manufacturing Change or Addition
006002033AP1991/05/17Control Supplement
006002032AP1993/02/18Labeling Revision
006002031AP1990/07/13Manufacturing Change or Addition
006002030AP1989/06/09Labeling Revision
006002028AP1987/06/18Manufacturing Change or Addition
006002027AP1987/03/27Labeling Revision
006002026AP1982/05/14Control Supplement
006002025AP1986/11/14Practioner Draft Labeling
006002024AP1986/10/14Practioner Draft Labeling
006002023AP1981/05/15Package Change
006002022AP1981/05/15Package Change
006002021AP1980/08/08Manufacturing Change or Addition
006002020AP1980/01/08Package Change
006002018AP1978/05/22Manufacturing Change or Addition
006002017AP1976/04/12Control Supplement
006002016AP1976/03/31Labeling Revision
006002015AP1975/01/29Control Supplement
006002000AP1949/10/31Approval