药品名称CORTISPORIN
申请号050168产品号002
活性成分BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE市场状态处方药
剂型或给药途径OINTMENT;TOPICAL规格400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM
治疗等效代码参比药物
批准日期1984/05/04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
050168078APLetter2003/11/28下载
050168078APLabel2003/12/02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
050168078AP2003/11/21Control Supplement
050168076AP2001/08/13Manufacturing Change or Addition
050168075AP1999/05/28Manufacturing Change or Addition
050168074AP1998/11/04Control Supplement
050168073AP1999/07/19Labeling Revision
050168070AP1982/03/26Manufacturing Change or Addition
050168069AP1981/10/20Manufacturing Change or Addition
050168067AP1978/06/19Control Supplement
050168066AP1977/05/06Manufacturing Change or Addition
050168065AP1977/01/13Labeling Revision
050168064AP1974/06/16Manufacturing Change or Addition
050168063AP1974/04/24Labeling Revision
050168062AP1974/02/12Manufacturing Change or Addition
050168061AP1972/10/17Manufacturing Change or Addition
050168060AP1972/10/16Labeling Revision
050168059AP1972/07/05Labeling Revision
050168058AP1972/06/23Labeling Revision
050168057AP1971/05/10Formulation Revision
050168056AP1973/05/23Labeling Revision
050168055AP1970/07/24Labeling Revision
050168054AP1970/06/15Labeling Revision
050168053AP1970/05/25Labeling Revision
050168052AP1970/08/11Formulation Revision
050168051AP1970/04/17Labeling Revision
050168050AP1970/04/07Labeling Revision
050168049AP1969/07/08Labeling Revision
050168047AP1969/03/04Manufacturing Change or Addition
050168046AP1968/08/14Control Supplement
050168045AP1968/07/02Labeling Revision
050168044AP1967/12/18Labeling Revision
050168043AP1967/08/11Labeling Revision
050168042AP1967/07/20Labeling Revision
050168041AP1967/07/20Labeling Revision
050168040AP1967/04/06Labeling Revision
050168039AP1967/03/03Labeling Revision
050168038AP1967/03/03Labeling Revision
050168037AP1967/02/24Labeling Revision
050168036AP1967/03/20Labeling Revision
050168035AP1967/02/10Labeling Revision
050168034AP1967/01/20Labeling Revision
050168032AP1967/01/13Labeling Revision
050168030AP1966/11/03Labeling Revision
050168028AP1966/08/26Labeling Revision
050168025AP1966/05/12Labeling Revision
050168023AP1965/06/08Labeling Revision
050168022AP1965/04/06Labeling Revision
050168021AP1965/03/22Labeling Revision
050168020AP1965/01/12Labeling Revision
050168019AP1965/01/11Labeling Revision
050168018AP1965/01/06Labeling Revision
050168017AP1964/12/22Labeling Revision
050168015AP1963/10/17Labeling Revision
050168014AP1963/10/04Labeling Revision
050168012AP1963/07/24Labeling Revision
050168010AP1962/06/01Labeling Revision
050168009AP1993/09/22Control Supplement
050168008AP1962/05/24Labeling Revision
050168007AP1962/05/24Labeling Revision
050168006AP1986/04/07Manufacturing Change or Addition
050168005AP1986/05/16Labeling Revision
050168004AP1985/12/04Labeling Revision
050168003AP1960/09/06Expiration Date Change
050168002AP1984/06/25Labeling Revision
050168001AP1983/07/06Manufacturing Change or Addition
050168000AP1957/03/26Approval