药品名称LIORESAL
申请号020075产品号001
活性成分BACLOFEN市场状态处方药
剂型或给药途径INJECTABLE;INTRATHECAL规格0.5MG/ML
治疗等效代码AP参比药物
批准日期1992/06/17申请机构SAOL THERAPEUTICS RESEARCH LTD
化学类型New dosage form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
020075032APLetter2016/10/04下载
020075032APLabel2016/10/06下载
020075031APLetter2014/11/21下载
020075028APLetter2013/11/20下载
020075028APLabel2013/11/22下载
020075026APLabel2013/03/08下载
020075024APLetter2011/11/16下载
020075024APLabel2011/11/16下载
020075021APLabel2011/03/29下载
020075021APLetter2011/03/29下载
020075020APLetter2003/05/30下载
020075019APLetter2003/01/17下载
020075017APLetter2002/11/20下载
020075016APLetter2002/03/06下载
020075014APLetter2002/03/06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
020075032AP2016/09/30Labeling Revision
020075031AP2014/11/19Labeling Revision
020075030AP2014/06/05Manufacturing Change or Addition
020075029AP2016/06/07Manufacturing Change or Addition
020075028AP2013/11/19Labeling Revision
020075027AP2013/09/05Manufacturing Change or Addition
020075026AP2013/03/06Manufacturing Change or Addition
020075025AP2013/01/10Manufacturing Change or Addition
020075024AP2011/11/13Labeling Revision
020075021AP2011/03/25Labeling Revision
020075020AP2003/05/08Package Change
020075019AP2003/01/17Manufacturing Change or Addition
020075018AP2002/12/10Manufacturing Change or Addition
020075017AP2002/11/21Package Change
020075016AP2002/03/06Labeling Revision
020075015AP2001/05/03Control Supplement
020075014AP2002/03/06Labeling Revision
020075012AP1999/05/05Manufacturing Change or Addition
020075009AP1998/08/21Expiration Date Change
020075008AP1998/08/21Manufacturing Change or Addition
020075007AP1998/06/23Manufacturing Change or Addition
020075006AP2000/03/03Manufacturing Change or Addition
020075005AP1996/11/07Formulation Revision
020075004AP1996/06/14New or Modified Indication
020075002AP1994/05/20Package Change
020075000AP1992/06/17Approval