药品名称VIVELLE
申请号020323产品号001
活性成分ESTRADIOL市场状态停止上市
剂型或给药途径FILM, EXTENDED RELEASE;TRANSDERMAL规格0.0375MG/24HR
治疗等效代码参比药物
批准日期1994/10/28申请机构NOVARTIS PHARMACEUTICALS CORP
化学类型New dosage form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
48141682008/03/04PDF格式
49942672008/03/04PDF格式
49942782008/03/04PDF格式
53002912011/04/05PDF格式
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
020323033APLetter2004/08/10下载
020323033APLabel2004/08/10下载
020323030APLabel2004/02/03下载
020323030APLetter2004/02/02下载
020323025APLetter2004/02/02下载
020323025APLabel2004/02/03下载
020323023APLetter2000/08/16下载
020323023APLabel2000/08/16下载
020323023APReview2004/04/13下载
020323021APReview2004/03/28下载
020323021APLetter2000/02/29下载
020323021APLabel2000/02/28下载
020323017APLetter2004/02/02下载
020323017APLabel2004/02/03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
020323033AP2004/08/06Labeling Revision
020323030AP2004/01/22Labeling Revision
020323029AP2002/07/18Control Supplement
020323028AP2002/03/28Control Supplement
020323027AP2001/10/31Control Supplement
020323026AP2001/07/03Manufacturing Change or Addition
020323025AP2004/01/22Labeling Revision
020323024AP2001/02/01Control Supplement
020323023AP2000/08/16Labeling Revision
020323022AP1999/10/29Control Supplement
020323021AP2000/02/25Efficacy Supplement with Clinical Data to Support
020323020AP1999/04/01Control Supplement
020323019AP1998/10/27Manufacturing Change or Addition
020323018AP1998/10/28Manufacturing Change or Addition
020323017AP2004/01/22Labeling Revision
020323016AP1997/07/23Control Supplement
020323015AP1997/07/22Control Supplement
020323014AP1997/05/29Labeling Revision
020323013AP1996/07/10Control Supplement
020323012AP1997/01/09Control Supplement
020323011AP1996/02/21Manufacturing Change or Addition
020323010AP1996/02/21Control Supplement
020323009AP1995/12/07Labeling Revision
020323008AP1995/12/11Labeling Revision
020323006AP1996/04/10Manufacturing Change or Addition
020323005AP1995/08/09Control Supplement
020323004AP1995/06/20Manufacturing Change or Addition
020323003AP1995/10/02Labeling Revision
020323002AP1995/06/09Control Supplement
020323001AP1995/03/21Control Supplement
020323000AP1994/10/28Approval