药品名称DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
申请号020201产品号006
活性成分DOBUTAMINE HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格EQ 400MG BASE/100ML
治疗等效代码AP参比药物
批准日期1994/07/07申请机构HOSPIRA 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
020201036APLetter2016/06/01下载
020201036APLabel2016/06/01下载
020201013APLetter2001/04/11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
020201036AP2016/05/31Labeling Revision
020201017AP2002/12/02Manufacturing Change or Addition
020201016AP2002/11/05Package Change
020201015AP2002/04/03Manufacturing Change or Addition
020201014AP2002/04/03Manufacturing Change or Addition
020201013AP2001/04/10Labeling Revision
020201012AP1999/09/01Labeling Revision
020201011AP1998/10/28Package Change
020201010AP1997/08/21Control Supplement
020201009AP1999/02/17Labeling Revision
020201008AP1995/08/03Manufacturing Change or Addition
020201006AP1996/06/26Control Supplement
020201005AP1995/08/17Package Change
020201004AP1994/07/07Labeling Revision
020201003AP1994/07/07Control Supplement
020201002AP1994/05/19Labeling Revision
020201001AP1994/02/24Manufacturing Change or Addition
020201000AP1993/09/27Approval