药品名称CATAFLAM
申请号020142产品号001
活性成分DICLOFENAC POTASSIUM市场状态停止上市
剂型或给药途径TABLET;ORAL规格25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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1993/11/24申请机构NOVARTIS PHARMACEUTICALS CORP
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
020142027APLabel2016/05/11下载
020142027APLetter2016/05/12下载
020142022APLetter2011/02/28下载
020142022APLabel2011/03/04下载
020142021APLetter2011/02/28下载
020142021APLabel2011/03/04下载
020142019APLetter2009/03/03下载
020142019APLabel2009/03/17下载
020142017APLabel2006/01/25下载
020142017APLetter2006/01/30下载
020142000APMedication 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
020142027AP2016/05/09Labeling Revision
020142026AP2014/11/24Manufacturing Change or Addition
020142022AP2011/02/23Labeling Revision
020142021AP2011/02/23Labeling Revision
020142019AP2009/02/25Labeling Revision
020142017AP2006/01/24Labeling Revision
020142015AP2002/09/19Control Supplement
020142014AP2002/03/11Manufacturing Change or Addition
020142013AP2001/07/13Manufacturing Change or Addition
020142012AP2000/09/15Manufacturing Change or Addition
020142011AP2000/07/10Manufacturing Change or Addition
020142009AP1999/04/22Package Change
020142008AP1997/11/12Control Supplement
020142007AP1997/05/16Manufacturing Change or Addition
020142006AP2001/10/31Labeling Revision
020142005AP1998/04/20Labeling Revision
020142004AP1995/11/28Manufacturing Change or Addition
020142003AP1995/07/28Labeling Revision
020142002AP1994/07/06Manufacturing Change or Addition
020142001AP1995/01/11Control Supplement
020142000AP1993/11/24Approval