药品名称PAMELOR
申请号018013产品号003
活性成分NORTRIPTYLINE HYDROCHLORIDE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格EQ 75MG BASE
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MALLINCKRODT LLC
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
018013063APLetter2014/07/29下载
018013063APLabel2014/07/29下载
018013062APLabel2014/07/11下载
018013062APLetter2014/07/11下载
018013061APLabel2012/10/26下载
018013061APLetter2012/10/29下载
018013058APLabel2007/07/16下载
018013058APLetter2007/07/24下载
018013056APLetter2005/01/13下载
018013056APLabel2005/01/13下载
018013053APReview2009/09/14下载
018013000APMedication Guide2009/11/20下载
018013000APOther 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
018013063AP2014/07/28Labeling Revision
018013062AP2014/07/10Labeling Revision
018013061AP2012/10/26Labeling Revision
018013058AP2007/07/13Labeling Revision
018013056AP2005/01/12Labeling Revision
018013055AP2004/12/06Manufacturing Change or Addition
018013054AP2001/06/07Manufacturing Change or Addition
018013053AP2001/07/31Labeling Revision
018013052AP2000/04/27Manufacturing Change or Addition
018013051AP1999/04/15Package Change
018013050AP1999/04/28Manufacturing Change or Addition
018013048AP1995/12/07Manufacturing Change or Addition
018013047AP1995/09/18Control Supplement
018013044AP1994/07/07Control Supplement
018013043AP1994/04/15Manufacturing Change or Addition
018013042AP1994/04/01Package Change
018013041AP1993/10/06Labeling Revision
018013039AP1993/07/23Package Change
018013038AP1993/08/17Formulation Revision
018013037AP1993/06/16Control Supplement
018013036AP1993/06/16Control Supplement
018013035AP1993/06/10Control Supplement
018013034AP1993/07/23Control Supplement
018013033AP1992/01/21Manufacturing Change or Addition
018013032AP1992/03/12Package Change
018013031AP1991/08/02Control Supplement
018013030AP1993/08/26Labeling Revision
018013029AP1991/03/13Labeling Revision
018013026AP1990/03/26Manufacturing Change or Addition
018013023AP1989/11/07Package Change
018013021AP1988/11/07Package Change
018013020AP1990/01/16Package Change
018013019AP1986/08/25Control Supplement
018013016AP1985/06/11Labeling Revision
018013015AP1985/06/27Formulation Revision
018013014AP1984/12/11Package Change
018013012AP1984/05/01Labeling Revision
018013010AP1982/06/02Control Supplement
018013009AP1982/03/25Package Change
018013008AP1981/06/26Manufacturing Change or Addition
018013007AP1981/07/24Package Change
018013005AP1979/11/20Labeling Revision
018013004AP1979/09/17Package Change
018013003AP1979/06/14Manufacturing Change or Addition
018013002AP1982/02/18General Efficacy (MarkIV)
018013001AP1978/06/29General Efficacy (MarkIV)
018013000AP1977/08/01Approval