药品名称NUBAIN
申请号018024产品号001
活性成分NALBUPHINE HYDROCHLORIDE市场状态停止上市
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Approved Prior to Jan 1, 1982申请机构PAR PHARMACEUTICAL 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
018024040APLetter2005/08/31下载
018024040APLabel2005/08/31下载
018024040APReview2007/08/06下载
018024036APLetter2003/05/30下载
018024036APReview2007/07/18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
018024040AP2005/08/23Supplement
018024039AP2002/10/25Control Supplement
018024038AP2002/01/15Control Supplement
018024037AP2002/04/16Manufacturing Change or Addition
018024036AP2003/04/30Labeling Revision
018024035AP1995/12/15Control Supplement
018024033AP1993/10/15Control Supplement
018024032AP1994/11/02Labeling Revision
018024031AP1990/10/19Manufacturing Change or Addition
018024029AP1988/11/10Formulation Revision
018024028AP1987/12/07Control Supplement
018024027AP1988/11/10Labeling Revision
018024026AP1987/08/04Labeling Revision
018024024AP1988/03/03Expiration Date Change
018024023AP1984/11/28Formulation Revision
018024022AP1984/09/13Manufacturing Change or Addition
018024021AP1984/09/13Manufacturing Change or Addition
018024020AP1984/09/17Control Supplement
018024019AP1983/08/17Manufacturing Change or Addition
018024018AP1983/08/17Manufacturing Change or Addition
018024017AP1983/02/16Labeling Revision
018024016AP1986/10/23New or Modified Indication
018024015AP1984/03/02Expiration Date Change
018024014AP1984/03/02Formulation Revision
018024013AP1982/05/20Manufacturing Change or Addition
018024012AP1982/05/20Package Change
018024011AP1982/05/27Expiration Date Change
018024010AP1982/05/27Formulation Revision
018024007AP1981/04/01Manufacturing Change or Addition
018024006AP1981/02/20Manufacturing Change or Addition
018024003AP1980/02/21Manufacturing Change or Addition
018024002AP1980/01/24Manufacturing Change or Addition
018024001AP1979/06/28Labeling Revision
018024000AP1979/05/15Approval