药品名称HALDOL
申请号015922产品号001
活性成分HALOPERIDOL LACTATE市场状态停止上市
剂型或给药途径CONCENTRATE;ORAL规格EQ 2MG BASE/ML
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ORTHO MCNEIL PHARMACEUTICAL
化学类型New dosage form审评分类Priority review drug
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与本品相关的市场独占权保护信息
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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
015922066AP2002/04/17Labeling Revision
015922065AP2000/05/02Labeling Revision
015922062AP1996/05/10Manufacturing Change or Addition
015922061AP1998/04/23Control Supplement
015922059AP1995/01/30Manufacturing Change or Addition
015922058AP1994/06/29Control Supplement
015922056AP1989/07/07Manufacturing Change or Addition
015922053AP1988/04/13Package Change
015922052AP1988/07/14Manufacturing Change or Addition
015922043AP1986/10/22Package Change
015922042AP1986/10/22Package Change
015922040AP1987/01/08Package Change
015922037AP1986/01/14Package Change
015922036AP1986/01/14Package Change
015922035AP1986/01/14Package Change
015922033AP1986/01/14Package Change
015922028AP1983/03/11Labeling Revision
015922027AP1983/01/31Labeling Revision
015922026AP1982/09/08Labeling Revision
015922025AP1982/04/20Manufacturing Change or Addition
015922024AP1982/06/23Manufacturing Change or Addition
015922023AP1981/10/02Labeling Revision
015922021AP1981/01/23Labeling Revision
015922020AP1981/01/23Labeling Revision
015922019AP1980/05/19Package Change
015922018AP1980/07/28Manufacturing Change or Addition
015922017AP1979/07/06Labeling Revision
015922016AP1980/01/15Manufacturing Change or Addition
015922015AP1979/07/06Labeling Revision
015922014AP1980/02/12Labeling Revision
015922013AP1979/04/12Manufacturing Change or Addition
015922012AP1978/02/13Labeling Revision
015922000AP1967/04/12Approval