药品名称TIMOPTIC-XE
申请号020330产品号001
活性成分TIMOLOL MALEATE市场状态处方药
剂型或给药途径SOLUTION, GEL FORMING/DROPS;OPHTHALMIC规格EQ 0.25% BASE
治疗等效代码AB参比药物
批准日期1993/11/04申请机构VALEANT PHARMACEUTICALS NORTH AMERICA LLC
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
48617602006/09/25PDF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
020330029APLetter2015/10/13下载
020330029APLabel2015/10/15下载
020330027APLabel2011/09/30下载
020330027APLetter2011/10/04下载
020330024APLabel2006/05/01下载
020330024APLetter2006/05/01下载
020330022APLetter2006/05/01下载
020330022APLabel2006/05/01下载
020330019APLabel2004/08/12下载
020330019APLetter2004/08/12下载
020330018APLabel2004/08/12下载
020330018APLetter2004/08/12下载
020330017APLetter2003/12/24下载
020330017APLabel2003/12/29下载
020330017APReview2006/05/08下载
020330011APReview2003/09/11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
020330030AP2015/10/20Manufacturing Change or Addition
020330029AP2015/10/08Labeling Revision
020330027AP2011/09/30Labeling Revision
020330024AP2006/04/26Labeling Revision
020330022AP2006/04/26Labeling Revision
020330019AP2004/08/11Labeling Revision
020330018AP2004/08/11Manufacturing Change or Addition
020330017AP2003/12/22Labeling Revision
020330016AP2001/12/04Manufacturing Change or Addition
020330015AP2001/12/03Labeling Revision
020330014AP2000/09/18Labeling Revision
020330013AP1999/06/07Control Supplement
020330012AP1999/02/02Control Supplement
020330011AP1998/03/18Labeling Revision
020330010AP1996/12/02Control Supplement
020330009AP1998/04/22Manufacturing Change or Addition
020330008AP1996/04/11Control Supplement
020330007AP1996/04/16Manufacturing Change or Addition
020330006AP1996/07/18Control Supplement
020330005AP1996/02/14Labeling Revision
020330004AP1995/04/25Package Change
020330003AP1995/05/18Labeling Revision
020330002AP1994/12/21Labeling Revision
020330001AP1994/06/22Control Supplement
020330000AP1993/11/04Approval