药品名称UNISOM
申请号018066产品号001
活性成分DOXYLAMINE SUCCINATE市场状态非处方药
剂型或给药途径TABLET;ORAL规格25MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构CHATTEM INC
化学类型New formulation or new manufacturer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
018066020APLetter2013/09/13下载
018066020APLabel2013/09/24下载
018066013APLetter2002/05/30下载
018066011APLetter2002/05/30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
018066020AP2013/09/12Labeling Revision
018066014AP2002/12/20Manufacturing Change or Addition
018066013AP2002/05/30Labeling Revision
018066012AP2002/04/26Manufacturing Change or Addition
018066011AP2002/05/30Labeling Revision
018066010AP1984/08/24Control Supplement
018066009AP1989/05/30Formulation Revision
018066008AP1984/02/23Control Supplement
018066007AP1983/03/11Package Change
018066006AP1987/08/12Expiration Date Change
018066005AP1982/08/05Expiration Date Change
018066004AP1982/08/05Expiration Date Change
018066003AP1981/12/21Control Supplement
018066002AP1981/08/31Expiration Date Change
018066001AP1978/02/13Package Change
018066000AP1978/10/18Approval