药品名称SINEQUAN
申请号016798产品号002
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 50MG 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PFIZER LABORATORIES DIV PFIZER INC
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
016798056APLabel2014/07/15下载
016798056APLetter2014/07/15下载
016798054APLabel2007/08/03下载
016798054APLetter2007/08/07下载
016798053APLetter2005/02/23下载
016798050APLetter2003/10/09下载
016798000APOther Important Information from FDA2007/05/09下载
016798000APMedication Guide2009/11/20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
016798056AP2014/07/14Labeling Revision
016798054AP2007/08/02Labeling Revision
016798053AP2005/02/18Labeling Revision
016798050AP2003/09/30Labeling Revision
016798048AP2000/04/10Labeling Revision
016798047AP2000/03/27Package Change
016798044AP1994/07/21Manufacturing Change or Addition
016798043AP1990/04/04Formulation Revision
016798040AP1988/10/27Control Supplement
016798039AP1988/10/27Control Supplement
016798038AP1987/09/01Package Change
016798035AP1985/10/28Package Change
016798034AP1984/09/13Labeling Revision
016798033AP1984/12/11Manufacturing Change or Addition
016798032AP1984/05/10Package Change
016798031AP1984/05/01Labeling Revision
016798030AP1983/09/26Package Change
016798029AP1983/09/26Package Change
016798028AP1983/07/22Control Supplement
016798027AP1981/02/12Package Change
016798026AP1980/08/12Formulation Revision
016798025AP1979/10/17Labeling Revision
016798024AP1978/07/07Control Supplement
016798023AP1978/07/12Package Change
016798022AP1978/06/06Formulation Revision
016798021AP1977/10/12Package Change
016798020AP1978/03/15Labeling Revision
016798019AP1978/03/15Manufacturing Change or Addition
016798018AP1976/10/28Package Change
016798017AP1976/03/11Control Supplement
016798016AP1976/06/04Control Supplement
016798014AP1975/04/07Control Supplement
016798012AP1975/03/31Control Supplement
016798011AP1975/06/13Distributor
016798000AP1969/09/23Approval