药品名称INFUVITE PEDIATRIC
申请号021265产品号001
活性成分ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K市场状态处方药
剂型或给药途径INJECTABLE;IV (INFUSION)规格80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL
治疗等效代码参比药物
批准日期2001/02/21申请机构SANDOZ CANADA 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
021265030APLetter2016/03/21下载
021265030APLabel2016/03/22下载
021265015APLetter2008/12/23下载
021265015APLabel2009/01/02下载
021265005APLetter2004/06/07下载
021265001APLabel2003/05/02下载
021265000APLetter2001/02/21下载
021265000APLabel2001/02/21下载
021265000APReview2001/02/21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
021265031AP2015/12/02Manufacturing Change or Addition
021265030AP2016/03/17Labeling Revision
021265026AP2014/11/11Manufacturing Change or Addition
021265025AP2014/09/04Manufacturing Change or Addition
021265015AP2008/12/17Control Supplement
021265005AP2003/02/12Labeling Revision
021265004AP2002/07/10Control Supplement
021265003AP2002/07/09Control Supplement
021265002AP2001/06/26Control Supplement
021265001AP2001/10/03Labeling Revision
021265000AP2001/02/21Approval