药品名称INDERAL LA
申请号018553产品号004
活性成分PROPRANOLOL HYDROCHLORIDE市场状态处方药
剂型或给药途径CAPSULE, EXTENDED RELEASE;ORAL规格60MG
治疗等效代码AB参比药物
批准日期1987/03/18申请机构ANI PHARMACEUTICALS INC
化学类型New dosage form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
018553037APLabel2011/03/21下载
018553037APLetter2011/03/23下载
018553036APLetter2007/11/08下载
018553035APLetter2007/03/06下载
018553034APLetter2007/01/08下载
018553030APLetter2004/06/10下载
018553015APReview2009/09/14下载
018553013APReview2009/09/14下载
018553012APReview2009/09/14下载
018553006APReview2009/09/14下载
018553005APReview2009/09/14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
018553039AP2015/12/21Manufacturing Change or Addition
018553038AP2015/10/22Manufacturing Change or Addition
018553037AP2011/03/17Labeling Revision
018553036AP2007/10/31Labeling Revision
018553035AP2007/02/21Labeling Revision
018553034AP2007/01/03Labeling Revision
018553030AP2004/06/09Labeling Revision
018553029AP2002/02/06Labeling Revision
018553028AP2000/03/31Manufacturing Change or Addition
018553027AP1999/08/22Labeling Revision
018553026AP1997/11/07Labeling Revision
018553025AP1990/04/17Control Supplement
018553024AP1990/02/09Formulation Revision
018553023AP1989/07/10Expiration Date Change
018553022AP1989/06/05Manufacturing Change or Addition
018553021AP1989/04/10Control Supplement
018553020AP1989/01/25Package Change
018553019AP1988/08/08Control Supplement
018553018AP1988/05/25Package Change
018553017AP1987/01/20Package Change
018553016AP1986/09/02Control Supplement
018553015AP1986/05/27Formulation Revision
018553013AP1987/03/18New Dosage Regimen
018553012AP1986/03/04Manufacturing Change or Addition
018553011AP1985/11/20Control Supplement
018553010AP1985/04/02Manufacturing Change or Addition
018553009AP1986/01/07Control Supplement
018553008AP1985/08/20General Efficacy (MarkIV)
018553006AP1985/03/21Labeling Revision
018553005AP1984/08/09Expiration Date Change
018553004AP1984/10/11Control Supplement
018553002AP1984/03/06Manufacturing Change or Addition
018553001AP1984/01/09General Efficacy (MarkIV)
018553000AP1983/04/19Approval