药品名称FUSILEV
申请号020140产品号003
活性成分LEVOLEUCOVORIN CALCIUM市场状态停止上市
剂型或给药途径SOLUTION;IV (INFUSION)规格EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期2011/04/29申请机构SPECTRUM PHARMACEUTICALS INC
化学类型New formulation or new manufacturer审评分类Standard review drug
罕用药/孤儿药
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
65008292022/03/07YYPDF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
ODE2018/04/29
历史市场独占权保护信息
I-6372014/04/29
ODE2015/03/07
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
020140002APLabel2011/05/02下载
020140002APLetter2011/05/04下载
020140001APLabel2008/07/15下载
020140001APLetter2008/07/15下载
020140000APReview2010/03/11下载
020140000APSummary Review2010/03/11下载
020140000APLetter2008/03/12下载
020140000APLabel2008/03/13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
020140020AP2016/09/15Manufacturing Change or Addition
020140018AP2014/06/24Manufacturing Change or Addition
020140017AP2012/11/09Manufacturing Change or Addition
020140002AP2011/04/29New or Modified Indication
020140001AP2008/07/14Labeling Revision
020140000AP2008/03/07Approval