药品名称COGENTIN
申请号012015产品号001
活性成分BENZTROPINE MESYLATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格1MG/ML
治疗等效代码AP参比药物
批准日期Approved Prior to Jan 1, 1982申请机构OAK PHARMACEUTICALS INC SUB AKORN INC
化学类型New dosage form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
012015027APLabel2013/04/22下载
012015027APLetter2013/04/24下载
012015026APLetter2013/04/24下载
012015026APLabel2013/04/22下载
012015023APLetter2001/05/22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
012015032AP2015/02/03Manufacturing Change or Addition
012015031AP2013/06/26Manufacturing Change or Addition
012015027AP2013/04/22Labeling Revision
012015026AP2013/04/22Labeling Revision
012015025AP1998/07/27Control Supplement
012015024AP1998/07/24Control Supplement
012015023AP2001/05/22Labeling Revision
012015022AP1996/04/15Manufacturing Change or Addition
012015021AP1996/09/26Labeling Revision
012015019AP1988/10/31Manufacturing Change or Addition
012015018AP1986/01/14Labeling Revision
012015016AP1981/11/02Package Change
012015015AP1981/10/19Manufacturing Change or Addition
012015014AP1981/05/14Control Supplement
012015013AP1979/04/19Labeling Revision
012015011AP1977/05/05Labeling Revision
012015009AP1975/01/15Labeling Revision
012015006AP1974/07/01Other Amendment
012015000AP1959/12/21Approval