药品名称PERMAX
申请号019385产品号003
活性成分PERGOLIDE MESYLATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格EQ 1MG BASE
治疗等效代码参比药物
批准日期1988/12/30申请机构VALEANT PHARMACEUTICALS INTERNATIONAL
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
47974052007/10/26PDF格式
51149482009/10/19PDF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
019385035APLetter2003/10/09下载
019385035APLabel2003/10/10下载
019385035APReview2009/01/12下载
019385031APReview2009/01/12下载
019385031APLetter2003/10/09下载
019385031APLabel2003/10/10下载
019385030APLabel2003/10/10下载
019385030APLetter2003/10/09下载
019385028APLetter2002/08/29下载
019385000APOther Important Information from FDA2007/03/29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
019385035AP2003/10/02Labeling Revision
019385032AP2002/05/17Control Supplement
019385031AP2003/10/02Labeling Revision
019385030AP2003/10/02Labeling Revision
019385029AP2000/12/07Control Supplement
019385028AP2002/08/29Labeling Revision
019385027AP1999/10/01Manufacturing Change or Addition
019385026AP1999/10/06Labeling Revision
019385025AP1999/04/13Manufacturing Change or Addition
019385024AP1998/06/26Manufacturing Change or Addition
019385022AP1998/04/13Manufacturing Change or Addition
019385021AP1998/04/03Package Change
019385020AP1999/10/06Labeling Revision
019385019AP1999/10/06Labeling Revision
019385017AP1999/10/06Labeling Revision
019385016AP1999/10/06Labeling Revision
019385014AP1994/11/29Formulation Revision
019385013AP1994/12/15Control Supplement
019385012AP1994/12/15Control Supplement
019385011AP1994/12/15Control Supplement
019385010AP1993/01/11Control Supplement
019385009AP1993/01/11Package Change
019385008AP1999/10/06Labeling Revision
019385007AP1993/01/08Package Change
019385006AP1991/05/15Control Supplement
019385005AP1993/01/08Manufacturing Change or Addition
019385004AP1999/10/06Labeling Revision
019385003AP1989/11/27Manufacturing Change or Addition
019385002AP1989/11/02Labeling Revision
019385001AP1989/03/17Control Supplement
019385000AP1988/12/30Approval