药品名称ALPHAGAN
申请号020613产品号001
活性成分BRIMONIDINE TARTRATE市场状态停止上市
剂型或给药途径SOLUTION/DROPS;OPHTHALMIC规格0.2%
治疗等效代码参比药物
批准日期1996/09/06申请机构ALLERGAN INC
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
020613031APLetter2016/03/25下载
020613031APLabel2016/03/29下载
020613018APLetter2001/12/20下载
020613018APLabel2001/12/20下载
020613018APReview2004/05/27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
020613031AP2016/03/23Labeling Revision
020613030AP2013/06/06Manufacturing Change or Addition
020613020AP2002/04/12Manufacturing Change or Addition
020613019AP2002/05/16Control Supplement
020613018AP2001/12/20Patient Population Altered
020613017AP2001/12/04Manufacturing Change or Addition
020613016AP2001/04/12Manufacturing Change or Addition
020613015AP2001/05/14Manufacturing Change or Addition
020613014AP2001/04/09Control Supplement
020613013AP2001/04/09Manufacturing Change or Addition
020613012AP2001/07/13Manufacturing Change or Addition
020613011AP2000/10/02Manufacturing Change or Addition
020613010AP2000/05/26Control Supplement
020613008AP1999/12/13Labeling Revision
020613007AP1999/08/26Control Supplement
020613006AP1999/12/13Labeling Revision
020613004AP1998/05/20Manufacturing Change or Addition
020613003AP1998/02/25Control Supplement
020613002AP1998/01/15Control Supplement
020613001AP1997/05/29Control Supplement
020613000AP1996/09/06Approval