药品名称H.P. ACTHAR GEL
申请号008372产品号006
活性成分CORTICOTROPIN市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格40 UNITS/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MALLINCKRODT ARD INC
化学类型New formulation or new manufacturer审评分类Standard 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
008372045APLetter2012/07/09下载
008372044APLetter2015/03/25下载
008372044APLabel2015/05/08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
008372051AP2016/04/19Manufacturing Change or Addition
008372050AP2016/03/14Manufacturing Change or Addition
008372049AP2016/03/11Manufacturing Change or Addition
008372048AP2016/03/04Manufacturing Change or Addition
008372047AP2014/01/17Manufacturing Change or Addition
008372045AP2012/07/05Labeling Revision
008372044AP2015/03/24Labeling Revision
008372035AP2002/11/06Expiration Date Change
008372034AP1999/07/15Manufacturing Change or Addition
008372033AP1998/12/15Package Change
008372031AP1994/04/05Package Change
008372030AP1993/03/26Package Change
008372029AP1992/04/22Labeling Revision
008372028AP1985/03/25Manufacturing Change or Addition
008372027AP1985/01/15Expiration Date Change
008372026AP1984/08/29Expiration Date Change
008372025AP1983/08/24Labeling Revision
008372024AP1981/03/26Labeling Revision
008372022AP1979/06/26Expiration Date Change
008372021AP1979/06/26Labeling Revision
008372020AP1979/06/26Distributor
008372018AP1979/06/26Labeling Revision
008372017AP1978/03/14Labeling Revision
008372016AP1977/10/05Labeling Revision
008372015AP1977/06/01Labeling Revision
008372000AP1952/04/29Approval