药品名称NORPACE CR
申请号018655产品号002
活性成分DISOPYRAMIDE PHOSPHATE市场状态处方药
剂型或给药途径CAPSULE, EXTENDED RELEASE;ORAL规格EQ 150MG BASE
治疗等效代码AB参比药物
批准日期1982/07/20申请机构GD SEARLE LLC
化学类型New dosage form审评分类Standard review drug
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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
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
018655033AP2000/05/17Labeling Revision
018655032AP1998/11/10Labeling Revision
018655031AP1998/07/17Control Supplement
018655030AP1998/02/03Labeling Revision
018655029AP1997/01/13Manufacturing Change or Addition
018655028AP1996/06/28Labeling Revision
018655027AP1993/12/21Package Change
018655026AP1991/07/03New or Modified Indication
018655025AP1992/01/16Labeling Revision
018655024AP1989/11/16Labeling Revision
018655023AP1989/10/20Labeling Revision
018655022AP1988/02/04Manufacturing Change or Addition
018655021AP1987/08/28Labeling Revision
018655020AP1987/06/30Manufacturing Change or Addition
018655019AP1987/02/12Labeling Revision
018655018AP1987/04/21Manufacturing Change or Addition
018655016AP1986/05/30Labeling Revision
018655015AP1986/05/06Manufacturing Change or Addition
018655014AP1985/11/26Expiration Date Change
018655013AP1985/06/18Labeling Revision
018655012AP1985/01/25Manufacturing Change or Addition
018655011AP1985/06/19Labeling Revision
018655010AP1984/02/29Labeling Revision
018655009AP1983/10/19Labeling Revision
018655008AP1985/06/19General Efficacy (MarkIV)
018655007AP1983/09/06Control Supplement
018655006AP1983/03/10Package Change
018655005AP1983/06/10Manufacturing Change or Addition
018655004AP1985/06/19Labeling Revision
018655002AP1982/09/22Control Supplement
018655001AP1982/09/21Labeling Revision
018655000AP1982/07/20Approval