药品名称LEUCOVORIN CALCIUM
申请号008107产品号005
活性成分LEUCOVORIN CALCIUM市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格EQ 350MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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1989/04/05申请机构HOSPIRA INC
化学类型New molecular entity (NME)审评分类Priority 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
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
008107055APLetter2003/12/22下载
008107054APReview2005/07/13下载
008107054APLetter2002/02/12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
008107055AP2003/12/17Manufacturing Change or Addition
008107054AP2002/02/12Labeling Revision
008107052AP1999/11/08Manufacturing Change or Addition
008107051AP1997/07/21Labeling Revision
008107050AP1996/05/24Labeling Revision
008107049AP1996/01/26Control Supplement
008107048AP1992/12/15Labeling Revision
008107046AP1990/09/11Control Supplement
008107043AP1989/08/23Control Supplement
008107042AP1992/03/10Package Change
008107040AP1991/12/12New or Modified Indication
008107039AP1988/08/31New or Modified Indication
008107038AP1989/04/05Control Supplement
008107036AP1988/05/23Formulation Revision
008107035AP1988/08/30Labeling Revision
008107034AP1987/01/30Practioner Draft Labeling
008107033AP1987/01/30New Route of Administration
008107032AP1987/01/30New Dosage Regimen
008107031AP1984/06/28Formulation Revision
008107030AP1984/02/22Control Supplement
008107029AP1983/03/29Labeling Revision
008107027AP1981/03/27Labeling Revision
008107026AP1981/01/27Manufacturing Change or Addition
008107025AP1980/12/22Formulation Revision
008107024AP1980/12/19Formulation Revision
008107023AP1980/09/04Manufacturing Change or Addition
008107022AP1980/02/05Package Change
008107021AP1980/01/16Control Supplement
008107020AP1980/04/28Control Supplement
008107019AP1979/07/25Formulation Revision
008107018AP1979/09/07Manufacturing Change or Addition
008107017AP1979/03/06Control Supplement
008107016AP1979/03/06Formulation Revision
008107015AP1979/03/09Control Supplement
008107014AP1977/11/11Control Supplement
008107013AP1977/08/15Control Supplement
008107000AP1952/06/20Approval