药品名称VIVACTIL
申请号016012产品号001
活性成分PROTRIPTYLINE HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格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TEVA WOMENS HEALTH INC
化学类型New molecular entity (NME)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
016012053APLetter2014/07/21下载
016012000APOther 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
016012053AP2014/07/17Labeling Revision
016012052AP2000/04/11Labeling Revision
016012051AP2000/04/11Labeling Revision
016012050AP2000/04/11Labeling Revision
016012049AP1998/11/04Control Supplement
016012048AP1997/12/04Control Supplement
016012047AP1996/12/27Control Supplement
016012046AP2000/03/27Labeling Revision
016012045AP1996/04/15Manufacturing Change or Addition
016012044AP2000/03/27Labeling Revision
016012043AP1994/06/01Manufacturing Change or Addition
016012042AP1993/08/26Control Supplement
016012041AP1988/04/08Package Change
016012040AP1987/04/13Labeling Revision
016012039AP1988/03/18Control Supplement
016012037AP1986/01/21Labeling Revision
016012036AP1985/09/20Labeling Revision
016012035AP1984/07/16Labeling Revision
016012034AP1983/06/09Control Supplement
016012032AP1982/02/18Labeling Revision
016012030AP1981/03/06Labeling Revision
016012029AP1981/03/10Formulation Revision
016012028AP1981/03/10Formulation Revision
016012027AP1980/05/12Labeling Revision
016012026AP1980/01/29Manufacturing Change or Addition
016012024AP1978/01/25Package Change
016012021AP1977/03/29Control Supplement
016012019AP1983/05/05Control Supplement
016012000AP1967/09/27Approval