药品名称CORTISPORIN
申请号050218产品号001
活性成分HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE市场状态处方药
剂型或给药途径CREAM;TOPICAL规格0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
治疗等效代码参比药物
批准日期1985/08/09申请机构MONARCH 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
050218051APLetter2004/06/02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
050218062AP2013/03/26Manufacturing Change or Addition
050218051AP2002/12/20Labeling Revision
050218050AP2001/03/21Manufacturing Change or Addition
050218049AP2000/07/13Manufacturing Change or Addition
050218048AP1998/11/20Control Supplement
050218047AP1999/07/19Labeling Revision
050218045AP1982/04/27Package Change
050218044AP1982/03/26Manufacturing Change or Addition
050218043AP1981/08/06Control Supplement
050218042AP1977/01/13Labeling Revision
050218041AP1974/05/01Labeling Revision
050218040AP1974/04/24Labeling Revision
050218039AP1974/03/08Labeling Revision
050218038AP1972/10/04Labeling Revision
050218037AP1972/07/27Labeling Revision
050218036AP1972/07/25Labeling Revision
050218035AP1972/06/21Labeling Revision
050218034AP1972/03/22Labeling Revision
050218033AP1971/05/11Formulation Revision
050218032AP1970/08/26Labeling Revision
050218031AP1970/07/27Labeling Revision
050218030AP1970/08/11Manufacturing Change or Addition
050218029AP1970/05/12Control Supplement
050218028AP1969/07/07Labeling Revision
050218027AP1969/04/25Labeling Revision
050218026AP1969/03/04Manufacturing Change or Addition
050218025AP1968/01/29Labeling Revision
050218024AP1967/06/19Labeling Revision
050218023AP1967/05/15Labeling Revision
050218022AP1967/03/29Control Supplement
050218021AP1967/03/20Labeling Revision
050218020AP1966/07/22Labeling Revision
050218018AP1966/11/30Package Change
050218017AP1965/01/28Expiration Date Change
050218016AP1965/01/12Control Supplement
050218015AP1964/07/15Labeling Revision
050218014AP1964/05/08Labeling Revision
050218013AP1964/05/08Control Supplement
050218012AP1964/03/03Labeling Revision
050218011AP1963/09/04Labeling Revision
050218010AP1963/07/24Labeling Revision
050218009AP1963/07/17Labeling Revision
050218008AP1963/07/24Labeling Revision
050218007AP1992/04/23Control Supplement
050218006AP1987/08/18Package Change
050218005AP1985/12/04Package Change
050218004AP1985/08/09Labeling Revision
050218003AP1985/08/09Labeling Revision
050218000AP1963/04/16Approval