药品名称NARCAN
申请号016636产品号003
活性成分NALOXONE HYDROCHLORIDE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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1982/06/14申请机构ADAPT PHARMA OPERATIONS LTD
化学类型New molecular entity (NME)审评分类Priority 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
016636054APLetter2002/02/11下载
016636054APLabel2015/03/02下载
016636052APLetter2002/02/11下载
016636052APLabel2015/03/02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
016636057AP2002/10/25Control Supplement
016636056AP2002/01/15Control Supplement
016636055AP2002/04/16Manufacturing Change or Addition
016636054AP2002/02/11Labeling Revision
016636053AP1996/09/06Control Supplement
016636052AP2002/02/11Labeling Revision
016636051AP1995/03/20Control Supplement
016636050AP1995/06/15Control Supplement
016636049AP1987/12/07Control Supplement
016636048AP1987/10/20Control Supplement
016636047AP1987/02/26Control Supplement
016636046AP1986/06/04Final Printed Labeling - MarkIV
016636043AP1986/06/04Control Supplement
016636042AP1986/06/04Control Supplement
016636041AP1986/06/04Control Supplement
016636039AP1984/09/17Formulation Revision
016636038AP1984/09/17Formulation Revision
016636036AP1984/09/25Manufacturing Change or Addition
016636035AP1984/10/15Control Supplement
016636034AP1985/07/23Labeling Revision
016636033AP1983/11/17Manufacturing Change or Addition
016636032AP1983/11/17Manufacturing Change or Addition
016636031AP1992/05/29New or Modified Indication
016636030AP1983/06/23Package Change
016636028AP1982/06/14Package Change
016636027AP1982/07/23Labeling Revision
016636026AP1982/05/19Package Change
016636024AP1981/05/14Package Change
016636023AP1981/05/14Manufacturing Change or Addition
016636022AP1981/09/30Labeling Revision
016636021AP1981/04/01Manufacturing Change or Addition
016636020AP1981/06/23Manufacturing Change or Addition
016636019AP1980/06/17Manufacturing Change or Addition
016636018AP1979/11/30Manufacturing Change or Addition
016636017AP1979/03/23Labeling Revision
016636016AP1978/10/20Control Supplement
016636015AP1976/04/06Labeling Revision
016636014AP1976/04/08Labeling Revision
016636013AP1975/09/24Labeling Revision
016636011AP1975/06/06Labeling Revision
016636009AP1974/12/09Distributor
016636008AP1975/06/05Labeling Revision
016636007AP1975/01/16Labeling Revision
016636005AP1975/04/04Control Supplement
016636004AP1975/04/04Control Supplement
016636000AP1971/04/13Approval