药品名称ASENDIN
申请号018021产品号003
活性成分AMOXAPINE市场状态停止上市
剂型或给药途径TABLET;ORAL规格100MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
化学类型New molecular entity (NME)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
018021000APOther Important Information from FDA2007/05/09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
018021041AP2001/09/25Labeling Revision
018021040AP1999/03/04Control Supplement
018021038AP1999/03/05Manufacturing Change or Addition
018021037AP2000/04/06Labeling Revision
018021036AP1997/05/14Control Supplement
018021035AP1997/02/06Manufacturing Change or Addition
018021034AP1996/08/29Control Supplement
018021033AP2000/04/06Labeling Revision
018021032AP1995/05/03Control Supplement
018021031AP1994/03/29Manufacturing Change or Addition
018021030AP1991/01/03Control Supplement
018021028AP2000/04/06Labeling Revision
018021027AP1988/02/18Labeling Revision
018021026AP1987/07/30Labeling Revision
018021025AP1987/06/04Control Supplement
018021024AP1988/02/18Labeling Revision
018021023AP1986/10/20Control Supplement
018021022AP1988/02/18Labeling Revision
018021021AP1988/02/18Other Amendment
018021019AP1985/06/06Labeling Revision
018021018AP1985/02/26Manufacturing Change or Addition
018021017AP1984/12/13Formulation Revision
018021016AP2000/04/06Labeling Revision
018021014AP1983/08/23Control Supplement
018021013AP1983/01/25Labeling Revision
018021012AP1982/10/04Labeling Revision
018021011AP1983/05/04Control Supplement
018021010AP1982/05/18Manufacturing Change or Addition
018021009AP1982/01/12Labeling Revision
018021007AP1981/12/22Package Change
018021006AP1981/06/22Package Change
018021005AP1981/06/22Labeling Revision
018021004AP1981/02/17Manufacturing Change or Addition
018021003AP1981/04/13Manufacturing Change or Addition
018021002AP1981/02/09Expiration Date Change
018021001AP1981/02/09Package Change
018021000AP1980/09/22Approval