药品名称LOXITANE
申请号017525产品号008
活性成分LOXAPINE SUCCINATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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Approved Prior to Jan 1, 1982申请机构ACTAVIS LABORATORIES UT INC
化学类型New molecular entity (NME)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
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
017525049AP1998/09/16Labeling Revision
017525048AP1997/01/28Control Supplement
017525047AP1996/03/25Manufacturing Change or Addition
017525046AP1995/02/27Package Change
017525043AP1991/12/16Manufacturing Change or Addition
017525042AP1994/06/29Control Supplement
017525041AP1994/03/29Manufacturing Change or Addition
017525040AP1990/07/25Manufacturing Change or Addition
017525038AP1989/07/18Manufacturing Change or Addition
017525037AP1989/04/28Manufacturing Change or Addition
017525033AP1987/02/03Control Supplement
017525031AP1986/05/02Manufacturing Change or Addition
017525029AP1985/05/14Manufacturing Change or Addition
017525024AP1983/10/17Control Supplement
017525023AP1982/09/13Manufacturing Change or Addition
017525022AP1983/04/19Expiration Date Change
017525021AP1983/03/10General Efficacy (MarkIV)
017525020AP1981/10/08Labeling Revision
017525019AP1981/10/08Labeling Revision
017525018AP1981/01/06Manufacturing Change or Addition
017525016AP1979/04/24Manufacturing Change or Addition
017525015AP1980/09/16Control Supplement
017525014AP1979/11/08Formulation Revision
017525013AP1978/06/08Formulation Revision
017525012AP1978/01/25Labeling Revision
017525011AP1978/06/08Formulation Revision
017525009AP1976/08/23Distributor
017525007AP1976/11/30Formulation Revision
017525005AP1976/05/04Control Supplement
017525004AP1976/05/04Control Supplement
017525003AP1976/05/04Control Supplement
017525002AP1977/06/03Control Supplement
017525000AP1975/02/25Approval