药品名称ANAFRANIL
申请号019906产品号003
活性成分CLOMIPRAMINE HYDROCHLORIDE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格75MG
治疗等效代码AB参比药物
批准日期1989/12/29申请机构MALLINCKRODT LLC
化学类型New molecular entity (NME)审评分类Priority 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
019906039APLetter2014/07/29下载
019906039APLabel2014/07/29下载
019906038APLabel2014/07/11下载
019906038APLetter2014/07/11下载
019906037APLabel2012/10/26下载
019906037APLetter2012/10/29下载
019906034APLabel2007/07/16下载
019906034APLetter2007/07/24下载
019906032APLetter2005/01/13下载
019906032APLabel2005/01/13下载
019906030APLetter2004/09/07下载
019906022APReview2007/06/12下载
019906009APLabel2003/06/10下载
019906000APOther Important Information from FDA2007/05/09下载
019906000APMedication Guide2009/11/16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
019906039AP2014/07/28Labeling Revision
019906038AP2014/07/10Labeling Revision
019906037AP2012/10/26Labeling Revision
019906034AP2007/07/13Labeling Revision
019906032AP2005/01/12Labeling Revision
019906030AP2004/09/03Labeling Revision
019906028AP2002/06/20Manufacturing Change or Addition
019906027AP2001/03/23Control Supplement
019906026AP2000/10/31Manufacturing Change or Addition
019906025AP2000/07/03Manufacturing Change or Addition
019906024AP1999/04/15Package Change
019906023AP1999/03/08Manufacturing Change or Addition
019906022AP1999/01/04Labeling Revision
019906021AP1998/05/18Control Supplement
019906020AP1998/01/15Labeling Revision
019906019AP1997/04/02Labeling Revision
019906018AP1997/02/11Control Supplement
019906017AP1997/04/02Labeling Revision
019906016AP1995/11/22Manufacturing Change or Addition
019906015AP1995/12/14Control Supplement
019906014AP1995/10/20Manufacturing Change or Addition
019906013AP1995/10/05Control Supplement
019906012AP1994/04/13Labeling Revision
019906011AP1994/07/13Control Supplement
019906010AP1994/07/01Control Supplement
019906009AP2001/07/31Labeling Revision
019906008AP1994/04/13Labeling Revision
019906007AP1991/04/09Labeling Revision
019906006AP1991/05/15Control Supplement
019906005AP1991/04/09Labeling Revision
019906004AP1991/01/31Formulation Revision
019906001AP1991/04/09Labeling Revision
019906000AP1989/12/29Approval