药品名称OPTISON
申请号020899产品号001
活性成分ALBUMIN HUMAN市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格10MG/ML
治疗等效代码参比药物
批准日期1997/12/31申请机构GE HEALTHCARE
化学类型New dosage form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
67233032021/04/20YPDF格式
历史专利信息
55297662013/06/25U-505PDF格式
55580942012/02/28U-505PDF格式
55737512012/04/25PDF格式
与本品相关的市场独占权保护信息
独占权代码失效日期
M-1202015/08/17
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
020899019APLetter2016/09/20下载
020899019APLabel2016/09/20下载
020899018APLabel2016/09/20下载
020899018APLetter2016/09/20下载
020899015APLetter2012/08/20下载
020899015APLabel2012/08/20下载
020899011APLetter2008/06/09下载
020899011APLabel2008/06/12下载
020899010APLetter2007/11/19下载
020899007APLetter2002/05/10下载
020899007APLabel2007/10/04下载
020899000APOther Important Information from FDA2008/07/11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
020899019AP2016/09/16Labeling Revision
020899018AP2016/09/16Labeling Revision
020899017AP2016/04/15Manufacturing Change or Addition
020899016AP2013/11/15Manufacturing Change or Addition
020899015AP2012/08/17Efficacy Supplement with Clinical Data to Support
020899011AP2008/06/06Labeling Revision
020899010AP2007/11/08Labeling Revision
020899007AP2002/05/10Manufacturing Change or Addition
020899006AP2000/12/18Manufacturing Change or Addition
020899005AP1999/05/06Manufacturing Change or Addition
020899004AP2000/02/04Manufacturing Change or Addition
020899003AP2000/03/14Labeling Revision
020899002AP1999/02/01Manufacturing Change or Addition
020899001AP1998/07/31Manufacturing Change or Addition
020899000AP1997/12/31Approval