药品名称DOXEPIN HYDROCHLORIDE
申请号016987产品号004
活性成分DOXEPIN HYDROCHLORIDE市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格EQ 100MG BASE
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构NEW RIVER PHARMACEUTICALS INC
化学类型New formulation or new manufacturer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
016987044AP1990/06/19Expiration Date Change
016987042AP1988/10/13Labeling Revision
016987039AP1987/11/03Package Change
016987038AP1987/11/03Package Change
016987037AP1988/01/22Labeling Revision
016987036AP1986/11/06Labeling Revision
016987035AP1987/11/05Expiration Date Change
016987034AP1986/06/16Expiration Date Change
016987033AP1986/03/19Package Change
016987032AP1986/10/20Package Change
016987031AP1985/01/22Labeling Revision
016987029AP1985/11/21Labeling Revision
016987028AP1984/08/24Expiration Date Change
016987027AP1984/08/22Control Supplement
016987026AP1984/04/11Labeling Revision
016987025AP1985/03/29Control Supplement
016987024AP1983/09/19Package Change
016987023AP1983/09/19Formulation Revision
016987022AP1983/04/25Control Supplement
016987018AP1987/04/13Formulation Revision
016987016AP1980/04/15Labeling Revision
016987015AP1980/01/15Formulation Revision
016987014AP1978/06/08Control Supplement
016987013AP1977/09/15Labeling Revision
016987011AP1977/12/12Control Supplement
016987010AP1975/04/28Efficacy (MarkIV)
016987000AP1972/01/31Approval