药品名称TIMOPTIC
申请号018086产品号002
活性成分TIMOLOL MALEATE市场状态处方药
剂型或给药途径SOLUTION/DROPS;OPHTHALMIC规格EQ 0.5% BASE
治疗等效代码AT1参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ATON PHARMA INC
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
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
018086076APLetter2016/08/10下载
018086076APLabel2016/08/10下载
018086075APLabel2011/09/30下载
018086075APLetter2011/10/03下载
018086072APLabel2006/05/01下载
018086072APLetter2006/05/01下载
018086070APLetter2006/05/01下载
018086070APLabel2006/05/01下载
018086060APLetter2003/12/24下载
018086060APLabel2003/12/29下载
018086060APReview2006/05/08下载
018086058APLetter2002/04/29下载
018086058APLabel2002/04/29下载
018086054APLabel2001/04/12下载
018086054APLetter2004/06/28下载
018086052APReview2003/09/11下载
018086047APReview2003/09/11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
018086076AP2016/08/09Labeling Revision
018086075AP2011/09/30Labeling Revision
018086072AP2006/04/26Labeling Revision
018086070AP2006/04/26Labeling Revision
018086062AP2002/12/06Package Change
018086060AP2003/12/22Control Supplement
018086059AP2002/04/17Control Supplement
018086058AP2002/04/29Labeling Revision
018086057AP2001/12/05Manufacturing Change or Addition
018086056AP2001/11/30Labeling Revision
018086054AP2001/04/12Package Change
018086053AP2000/09/18Labeling Revision
018086052AP1998/03/18Labeling Revision
018086051AP1997/08/05Labeling Revision
018086050AP1996/12/02Control Supplement
018086049AP1998/04/22Manufacturing Change or Addition
018086048AP1996/04/16Manufacturing Change or Addition
018086047AP1997/05/16Labeling Revision
018086046AP1996/07/18Control Supplement
018086045AP1995/04/25Package Change
018086044AP1995/02/24Labeling Revision
018086043AP1995/02/24Labeling Revision
018086042AP1993/12/09Labeling Revision
018086038AP1992/05/20Labeling Revision
018086037AP1992/05/20Labeling Revision
018086036AP1990/03/19Control Supplement
018086035AP1992/05/20Labeling Revision
018086034AP1988/01/15Manufacturing Change or Addition
018086033AP1987/08/04Labeling Revision
018086032AP1987/08/04Labeling Revision
018086031AP1986/11/28Manufacturing Change or Addition
018086030AP1987/06/05Control Supplement
018086029AP1986/02/27Labeling Revision
018086028AP1987/08/04Labeling Revision
018086027AP1984/11/29Manufacturing Change or Addition
018086026AP1986/02/12Manufacturing Change or Addition
018086024AP1984/06/14Manufacturing Change or Addition
018086022AP1983/09/07Control Supplement
018086019AP1982/06/30Manufacturing Change or Addition
018086018AP1981/11/03Labeling Revision
018086017AP1981/10/27Manufacturing Change or Addition
018086016AP1981/10/09Control Supplement
018086015AP1981/10/09Labeling Revision
018086014AP1987/08/04Practioner Draft Labeling
018086013AP1981/03/31Final Printed Labeling - MarkIV
018086012AP1981/07/15Manufacturing Change or Addition
018086011AP1980/06/20Control Supplement
018086010AP1980/05/21Labeling Revision
018086009AP1980/02/11Labeling Revision
018086007AP1980/05/13Final Printed Labeling - MarkIV
018086006AP1979/07/20Labeling Revision
018086005AP1979/12/03Labeling Revision
018086004AP1979/04/06Labeling Revision
018086002AP1980/01/02Labeling Revision
018086001AP1980/01/08Labeling Revision
018086000AP1978/08/17Approval