药品名称KINEVAC
申请号017697产品号001
活性成分SINCALIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格0.005MG/VIAL
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构BRACCO DIAGNOSTICS INC
化学类型New molecular entity (NME)审评分类Priority 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
68030462022/08/16YPDF格式
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
017697017APLetter2005/04/28下载
017697015APLetter2004/06/07下载
017697015APReview2012/11/09下载
017697014APLetter2004/06/07下载
017697014APReview2012/11/09下载
017697013APReview2012/11/09下载
017697013APLetter2004/06/07下载
017697012APLetter2004/06/07下载
017697012APReview2012/11/09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
017697028AP2016/08/17Manufacturing Change or Addition
017697027AP2016/02/17Manufacturing Change or Addition
017697026AP2015/08/18Manufacturing Change or Addition
017697025AP2015/05/29Manufacturing Change or Addition
017697024AP2015/01/22Manufacturing Change or Addition
017697023AP2014/07/18Manufacturing Change or Addition
017697017AP2005/04/26Labeling Revision
017697015AP2002/11/27Control Supplement
017697014AP2002/11/27Package Change
017697013AP2002/11/27Formulation Revision
017697012AP2002/11/27Manufacturing Change or Addition
017697011AP2002/10/29Manufacturing Change or Addition
017697010AP1992/12/22Labeling Revision
017697009AP1988/05/25Labeling Revision
017697006AP1985/07/15Manufacturing Change or Addition
017697005AP1986/08/25New or Modified Indication
017697004AP1979/10/18Control Supplement
017697001AP1977/09/14Control Supplement
017697000AP1976/07/21Approval