药品名称TENUATE DOSPAN
申请号012546产品号001
活性成分DIETHYLPROPION HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET, EXTENDED RELEASE;ORAL规格75MG
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ACTAVIS LABORATORIES UT INC
化学类型New active ingredient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
012546032APLabel2004/09/07下载
012546032APLetter2004/09/07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
012546033AP2013/12/19Manufacturing Change or Addition
012546032AP2004/09/03Labeling Revision
012546031AP2002/04/16Formulation Revision
012546030AP2000/02/09Control Supplement
012546029AP1999/05/06Labeling Revision
012546027AP1998/02/02Labeling Revision
012546025AP1998/02/02Labeling Revision
012546024AP1988/07/21Package Change
012546022AP1986/10/03Control Supplement
012546021AP1985/08/22Package Change
012546020AP1983/12/23Manufacturing Change or Addition
012546019AP1983/06/08Control Supplement
012546018AP1982/12/06Labeling Revision
012546017AP1988/06/17Labeling Revision
012546016AP1982/10/18Package Change
012546015AP1979/11/06Control Supplement
012546014AP1978/04/27Package Change
012546011AP1976/09/27Package Change
012546009AP1975/06/24Control Supplement
012546000AP1960/11/17Approval