药品名称MAXITROL
申请号050065产品号002
活性成分DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE市场状态处方药
剂型或给药途径OINTMENT;OPHTHALMIC规格0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
治疗等效代码AT参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ALCON LABORATORIES INC
化学类型审评分类
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
050065044APLetter2004/07/21下载
050065044APLabel2004/07/21下载
050065043APLetter2004/07/21下载
050065043APLabel2004/07/21下载
050065040APLabel2003/07/28下载
050065040APLetter2003/07/28下载
050065039APLabel2003/07/28下载
050065039APLetter2003/07/28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
050065060AP2015/10/06Manufacturing Change or Addition
050065058AP2012/12/10Manufacturing Change or Addition
050065057AP2012/12/18Manufacturing Change or Addition
050065044AP2004/07/15Package Change
050065043AP2004/07/15Labeling Revision
050065041AP2002/12/11Control Supplement
050065040AP2003/07/23Labeling Revision
050065039AP2003/07/23Manufacturing Change or Addition
050065038AP2001/02/09Manufacturing Change or Addition
050065037AP1999/09/28Package Change
050065036AP1999/04/07Manufacturing Change or Addition
050065035AP1999/02/05Manufacturing Change or Addition
050065034AP1998/05/29Manufacturing Change or Addition
050065032AP1996/11/29Control Supplement
050065031AP1996/03/18Control Supplement
050065030AP1995/05/18Formulation Revision
050065029AP1995/08/30Labeling Revision
050065028AP1983/07/11Control Supplement
050065027AP1982/07/29Labeling Revision
050065026AP1981/06/17Control Supplement
050065025AP1981/04/13Control Supplement
050065024AP1978/05/10Labeling Revision
050065023AP1973/02/20Control Supplement
050065022AP1973/02/08Control Supplement
050065021AP1973/02/08Control Supplement
050065020AP1972/09/19Labeling Revision
050065019AP1972/07/12Control Supplement
050065018AP1972/04/17Control Supplement
050065017AP1972/04/10Package Change
050065016AP1971/08/09Labeling Revision
050065015AP1971/07/22Labeling Revision
050065014AP1970/06/04Control Supplement
050065013AP1992/02/03Control Supplement
050065010AP1992/09/17Package Change
050065009AP1988/03/22Control Supplement
050065008AP1987/05/15Labeling Revision
050065007AP1987/06/30Labeling Revision
050065006AP1987/06/30Manufacturing Change or Addition
050065005AP1984/07/25Control Supplement
050065004AP1984/04/23Control Supplement
050065003AP1983/12/30Labeling Revision
050065002AP1983/11/23Control Supplement
050065001AP1983/07/11Control Supplement
050065000AP1963/07/19Approval