药品名称COLY-MYCIN S
申请号050356产品号001
活性成分COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE市场状态处方药
剂型或给药途径SUSPENSION/DROPS;OTIC规格EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ENDO PHARMACEUTICALS 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
050356050APLabel2009/06/04下载
050356050APLetter2009/06/08下载
050356045APLetter2002/03/01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
050356056AP2016/03/29Manufacturing Change or Addition
050356055AP2013/12/06Manufacturing Change or Addition
050356050AP2009/06/02Labeling Revision
050356048AP2001/12/05Package Change
050356047AP2001/09/27Manufacturing Change or Addition
050356046AP1997/04/23Control Supplement
050356045AP2002/03/01Labeling Revision
050356044AP1994/08/02Control Supplement
050356043AP1997/01/08Labeling Revision
050356042AP1982/08/03Manufacturing Change or Addition
050356041AP1982/03/05Manufacturing Change or Addition
050356040AP1982/03/18Control Supplement
050356039AP1981/10/19Manufacturing Change or Addition
050356038AP1980/10/15Labeling Revision
050356037AP1979/10/17Labeling Revision
050356036AP1978/07/19Package Change
050356035AP1976/11/18Package Change
050356034AP1972/10/16Labeling Revision
050356032AP1968/11/20Package Change
050356031AP1967/11/24Control Supplement
050356030AP1967/07/17Control Supplement
050356029AP1967/07/14Labeling Revision
050356028AP1967/04/18Labeling Revision
050356027AP1967/03/08Labeling Revision
050356026AP1967/01/31Labeling Revision
050356025AP1967/01/31Labeling Revision
050356024AP1966/12/21Labeling Revision
050356023AP1966/10/31Control Supplement
050356022AP1966/12/30Control Supplement
050356021AP1966/05/20Manufacturing Change or Addition
050356020AP1966/04/22Labeling Revision
050356018AP1966/01/07Formulation Revision
050356017AP1965/11/15Labeling Revision
050356016AP1965/12/14Package Change
050356015AP1965/07/27Labeling Revision
050356014AP1965/04/16Labeling Revision
050356012AP1965/05/26Package Change
050356010AP1964/08/20Control Supplement
050356009AP1964/05/14Control Supplement
050356008AP1964/04/16Expiration Date Change
050356007AP1964/04/16Control Supplement
050356006AP1991/07/01Manufacturing Change or Addition
050356005AP1986/03/17Expiration Date Change
050356004AP1985/12/17Manufacturing Change or Addition
050356003AP1984/03/23Package Change
050356002AP1983/09/13Formulation Revision
050356001AP1982/12/28Control Supplement
050356000AP1962/05/17Approval