药品名称LIMBITROL
申请号016949产品号001
活性成分AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格EQ 12.5MG BASE;5MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构HERITAGE PHARMACEUTICALS INC
化学类型New combination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
016949039APLetter2016/04/27下载
016949039APLabel2016/04/27下载
016949038APLabel2007/08/06下载
016949038APLetter2007/08/07下载
016949035APLetter2005/01/13下载
016949035APLabel2005/01/13下载
016949033APLetter2001/06/05下载
016949000APOther Important Information from FDA2007/05/09下载
016949000APMedication Guide2009/11/19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
016949039AP2016/04/25Labeling Revision
016949038AP2007/08/03Labeling Revision
016949035AP2005/01/12Labeling Revision
016949034AP2001/12/19Manufacturing Change or Addition
016949033AP2001/06/05Labeling Revision
016949032AP2000/03/28Labeling Revision
016949031AP2000/03/28Labeling Revision
016949029AP1992/12/28Control Supplement
016949028AP1990/01/16Package Change
016949027AP2000/03/28Labeling Revision
016949026AP1988/06/09Control Supplement
016949025AP1985/11/19Labeling Revision
016949024AP1985/04/17Labeling Revision
016949022AP1984/06/26Control Supplement
016949020AP1982/09/20Control Supplement
016949019AP1982/09/20Control Supplement
016949018AP1982/03/22Manufacturing Change or Addition
016949014AP1980/05/19Formulation Revision
016949013AP1980/03/28Labeling Revision
016949012AP1980/05/19Formulation Revision
016949011AP1980/01/21Formulation Revision
016949010AP1979/08/15Manufacturing Change or Addition
016949009AP1978/09/25Labeling Revision
016949008AP1979/09/07Manufacturing Change or Addition
016949006AP1978/08/22Package Change
016949005AP1978/07/24Manufacturing Change or Addition
016949004AP1978/04/17Formulation Revision
016949003AP1980/09/09Control Supplement
016949002AP1980/09/09Control Supplement
016949001AP1980/09/09Package Change
016949000AP1977/12/23Approval