药品名称LUVOX
申请号020243产品号003
活性成分FLUVOXAMINE MALEATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1994/12/05申请机构SOLVAY PHARMACEUTICALS
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
020243021APLetter2000/09/28下载
020243021APReview2004/06/08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
020243023AP2001/09/06Labeling Revision
020243022AP2000/08/09Labeling Revision
020243021AP2000/09/28New Dosage Regimen
020243020AP2000/06/01Labeling Revision
020243019AP2000/06/01Labeling Revision
020243018AP1999/10/21Manufacturing Change or Addition
020243015AP1998/12/08Labeling Revision
020243014AP2000/06/01Labeling Revision
020243013AP2000/06/01Labeling Revision
020243009AP1996/11/13Labeling Revision
020243008AP1996/12/02Control Supplement
020243007AP1996/08/29Manufacturing Change or Addition
020243006AP1997/03/25Patient Population Altered
020243005AP1996/03/19Labeling Revision
020243004AP1996/01/18Manufacturing Change or Addition
020243003AP1995/08/14Manufacturing Change or Addition
020243002AP1995/04/12Labeling Revision
020243001AP1995/02/21Expiration Date Change
020243000AP1994/12/05Approval