药品名称PHENDIMETRAZINE TARTRATE
申请号018074产品号001
活性成分PHENDIMETRAZINE TARTRATE市场状态处方药
剂型或给药途径CAPSULE, EXTENDED RELEASE;ORAL规格105MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构SANDOZ INC
化学类型New formulation or new manufacturer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
018074034APLetter2012/02/14下载
018074034APLabel2012/02/24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
018074034AP2012/02/10Labeling Revision
018074030AP1999/11/08Manufacturing Change or Addition
018074029AP1999/06/16Labeling Revision
018074028AP1998/11/03Labeling Revision
018074027AP1998/09/23Control Supplement
018074026AP1996/02/02Control Supplement
018074025AP1995/08/30Package Change
018074024AP1995/02/17Manufacturing Change or Addition
018074023AP1994/04/25Manufacturing Change or Addition
018074022AP1994/04/25Manufacturing Change or Addition
018074021AP1985/04/01Manufacturing Change or Addition
018074020AP1985/05/03Manufacturing Change or Addition
018074019AP1982/11/19Control Supplement
018074018AP1981/09/10Control Supplement
018074017AP1981/09/10Control Supplement
018074016AP1981/03/23Manufacturing Change or Addition
018074015AP1981/02/25Distributor
018074014AP1980/09/25Formulation Revision
018074013AP1981/05/05Distributor
018074010AP1980/08/18Expiration Date Change
018074009AP1980/02/28Distributor
018074005AP1980/02/01Distributor
018074004AP1979/11/26Labeling Revision
018074003AP1979/10/26Formulation Revision
018074002AP1979/10/15Control Supplement
018074001AP1979/10/15Control Supplement
018074000AP1979/04/16Approval