药品名称VERELAN
申请号019614产品号003
活性成分VERAPAMIL HYDROCHLORIDE市场状态处方药
剂型或给药途径CAPSULE, EXTENDED RELEASE;ORAL规格180MG
治疗等效代码AB参比药物
批准日期1992/01/09申请机构RECRO GAINESVILLE LLC
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
48637422007/06/19U-3PDF格式
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
019614050APLetter2014/10/10下载
019614050APLabel2014/10/15下载
019614049APLabel2011/11/14下载
019614049APLetter2011/11/16下载
019614045APLetter2010/04/02下载
019614045APLabel2010/04/04下载
019614034APLetter2010/04/09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
019614050AP2014/10/09Labeling Revision
019614049AP2011/11/14Labeling Revision
019614045AP2010/03/30Labeling Revision
019614034AP2010/03/30Labeling Revision
019614032AP2000/11/29Manufacturing Change or Addition
019614031AP2000/07/27Manufacturing Change or Addition
019614030AP1999/12/13Manufacturing Change or Addition
019614028AP1999/07/02Manufacturing Change or Addition
019614027AP1999/06/05Labeling Revision
019614026AP1998/10/15Manufacturing Change or Addition
019614025AP1997/07/29Labeling Revision
019614024AP1998/07/14Labeling Revision
019614023AP1997/12/30Control Supplement
019614022AP1997/04/23Manufacturing Change or Addition
019614020AP1996/05/31Manufacturing Change or Addition
019614019AP1996/05/31Manufacturing Change or Addition
019614018AP1996/05/16Manufacturing Change or Addition
019614017AP1996/02/01Manufacturing Change or Addition
019614016AP1995/08/02Expiration Date Change
019614013AP1996/05/10Formulation Revision
019614012AP1993/11/08Labeling Revision
019614011AP1995/06/21Labeling Revision
019614010AP1994/03/30Package Change
019614009AP1993/12/06Labeling Revision
019614008AP1992/10/02Labeling Revision
019614007AP1992/10/02Labeling Revision
019614006AP1994/10/12Labeling Revision
019614005AP1991/09/13Labeling Revision
019614004AP1991/06/06Labeling Revision
019614003AP1992/01/09Formulation Revision
019614002AP1994/08/18Expiration Date Change
019614001AP1994/04/05Control Supplement
019614000AP1990/05/29Approval