药品名称VOLTAREN
申请号019201产品号002
活性成分DICLOFENAC SODIUM市场状态停止上市
剂型或给药途径TABLET, DELAYED RELEASE;ORAL规格50MG
治疗等效代码参比药物
批准日期1988/07/28申请机构NOVARTIS PHARMACEUTICALS CORP
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
019201046APLabel2016/05/11下载
019201046APLetter2016/05/12下载
019201040APLetter2011/02/28下载
019201040APLabel2011/03/04下载
019201039APLetter2011/02/28下载
019201039APLabel2011/03/04下载
019201038APLetter2009/02/27下载
019201038APLabel2009/03/17下载
019201036APLabel2007/07/10下载
019201036APLetter2007/07/16下载
019201035APLabel2006/01/25下载
019201035APLetter2006/01/30下载
019201018APLetter2002/11/26下载
019201018APReview2005/02/08下载
019201000APMedication Guide2009/12/04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
019201046AP2016/05/09Labeling Revision
019201045AP2014/06/05Manufacturing Change or Addition
019201043AP2013/01/25Manufacturing Change or Addition
019201040AP2011/02/23Labeling Revision
019201039AP2011/02/23Labeling Revision
019201038AP2009/02/25Labeling Revision
019201036AP2007/07/09Labeling Revision
019201035AP2006/01/24Labeling Revision
019201033AP2002/09/19Control Supplement
019201032AP2002/03/11Manufacturing Change or Addition
019201031AP2001/09/28Control Supplement
019201030AP2000/10/23Manufacturing Change or Addition
019201029AP2000/09/20Control Supplement
019201028AP2000/02/18Manufacturing Change or Addition
019201027AP1999/04/22Package Change
019201026AP1999/02/09Manufacturing Change or Addition
019201025AP1997/05/16Manufacturing Change or Addition
019201024AP1997/03/11Control Supplement
019201023AP2001/10/31Labeling Revision
019201022AP1998/04/20Labeling Revision
019201021AP1995/12/22Manufacturing Change or Addition
019201020AP1995/07/28Labeling Revision
019201019AP1995/11/02Manufacturing Change or Addition
019201018AP2002/11/26Labeling Revision
019201017AP1994/12/08Control Supplement
019201015AP1993/01/04Control Supplement
019201014AP1993/04/20Manufacturing Change or Addition
019201013AP1992/04/21Control Supplement
019201010AP1990/01/24Labeling Revision
019201009AP1990/02/12Control Supplement
019201007AP1989/09/27Package Change
019201005AP1991/02/12Control Supplement
019201004AP1988/12/30Labeling Revision
019201003AP1989/02/06Manufacturing Change or Addition
019201002AP1989/07/11Control Supplement
019201001AP1989/07/20Control Supplement
019201000AP1988/07/28Approval