药品名称OXYTOCIN
申请号018248产品号001
活性成分OXYTOCIN市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格10USP UNITS/ML (10USP UNITS/ML)
治疗等效代码AP参比药物
批准日期Approved Prior to Jan 1, 1982申请机构FRESENIUS KABI USA LLC
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
018248034APLetter2007/07/30下载
018248027APReview2007/07/09下载
018248026APReview2007/07/09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
018248044AP2016/09/15Manufacturing Change or Addition
018248042AP2014/09/10Manufacturing Change or Addition
018248034AP2007/07/27Control Supplement
018248028AP2000/10/11Expiration Date Change
018248027AP2000/05/31Labeling Revision
018248026AP1999/02/22Labeling Revision
018248025AP1999/07/02Control Supplement
018248024AP1997/10/17Manufacturing Change or Addition
018248023AP1994/11/23Labeling Revision
018248022AP1995/01/13Control Supplement
018248020AP1994/12/16Control Supplement
018248019AP1999/01/20Manufacturing Change or Addition
018248018AP1988/02/16Package Change
018248017AP1987/02/24Labeling Revision
018248016AP1986/09/19Control Supplement
018248015AP1986/10/14Labeling Revision
018248014AP1985/03/14Control Supplement
018248013AP1984/07/23Control Supplement
018248012AP1983/11/08Control Supplement
018248011AP1983/08/10Labeling Revision
018248009AP1982/11/12Control Supplement
018248008AP1983/04/14Practioner Draft Labeling
018248007AP1982/03/10Manufacturing Change or Addition
018248000AP1980/07/09Approval