药品名称ELAVIL
申请号012703产品号003
活性成分AMITRIPTYLINE HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格25MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ASTRAZENECA PHARMACEUTICALS LP
化学类型New molecular entity (NME)审评分类Priority 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
012703093APLetter2003/08/06下载
012703092APLetter2001/03/27下载
012703000APOther Important Information from FDA2007/05/09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
012703093AP2003/07/29Labeling Revision
012703092AP2001/03/27Labeling Revision
012703091AP2001/01/22Control Supplement
012703090AP2000/04/05Labeling Revision
012703089AP1998/12/24Manufacturing Change or Addition
012703088AP2000/04/05Labeling Revision
012703087AP1996/12/30Package Change
012703086AP2000/04/05Labeling Revision
012703085AP1995/07/13Control Supplement
012703084AP2000/04/05Labeling Revision
012703083AP1994/06/01Formulation Revision
012703082AP1994/06/01Control Supplement
012703081AP1991/06/24Labeling Revision
012703080AP1989/07/28Manufacturing Change or Addition
012703079AP1991/06/24Labeling Revision
012703078AP1988/04/08Package Change
012703077AP1988/12/12Formulation Revision
012703076AP1991/06/24Labeling Revision
012703075AP1988/02/26Control Supplement
012703074AP1986/04/02Expiration Date Change
012703073AP1986/07/10Labeling Revision
012703072AP1985/09/20Labeling Revision
012703071AP1984/09/13Package Change
012703070AP1984/08/15Package Change
012703069AP1984/03/07Manufacturing Change or Addition
012703068AP1983/03/15Labeling Revision
012703067AP1983/05/26Manufacturing Change or Addition
012703065AP1984/05/21Labeling Revision
012703064AP1983/05/03Control Supplement
012703062AP1981/06/25Manufacturing Change or Addition
012703061AP1981/03/23Labeling Revision
012703060AP1980/09/03Labeling Revision
012703059AP1980/06/23Labeling Revision
012703058AP1981/03/02Formulation Revision
012703057AP1981/09/04Formulation Revision
012703056AP1981/03/02Manufacturing Change or Addition
012703054AP1980/03/04Labeling Revision
012703053AP1980/01/29Labeling Revision
012703052AP1979/11/06Labeling Revision
012703050AP1981/03/02Manufacturing Change or Addition
012703049AP1980/01/29Manufacturing Change or Addition
012703046AP1978/01/25Package Change
012703044AP1977/03/01Package Change
012703043AP1976/08/02Control Supplement
012703042AP1976/09/17Labeling Revision
012703041AP1976/08/02Control Supplement
012703039AP1976/10/28Labeling Revision
012703038AP1975/09/18Labeling Revision
012703037AP1975/09/18Labeling Revision
012703036AP1975/09/17Control Supplement
012703035AP1975/09/17Control Supplement
012703032AP1981/03/09Control Supplement
012703000AP1961/04/07Approval