药品名称RETIN-A
申请号017522产品号001
活性成分TRETINOIN市场状态处方药
剂型或给药途径CREAM;TOPICAL规格0.05%
治疗等效代码AB1参比药物
批准日期Approved Prior to Jan 1, 1982申请机构VALEANT INTERNATIONAL BERMUDA
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
017522026APLetter2002/06/10下载
017522026APLabel2002/06/10下载
017522023APLabel2002/06/10下载
017522023APLetter2002/06/10下载
017522022APLetter2002/06/10下载
017522022APLabel2002/06/10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
017522038AP2016/05/13Manufacturing Change or Addition
017522036AP2013/01/08Manufacturing Change or Addition
017522028AP2002/12/06Manufacturing Change or Addition
017522027AP2001/03/20Package Change
017522026AP2002/06/10Labeling Revision
017522025AP1999/01/25Manufacturing Change or Addition
017522024AP1998/07/23Manufacturing Change or Addition
017522023AP2002/06/10Labeling Revision
017522022AP2002/06/10Labeling Revision
017522020AP1992/01/24Control Supplement
017522019AP1990/07/03Control Supplement
017522018AP1990/08/28Labeling Revision
017522017AP1990/08/28Labeling Revision
017522016AP1989/12/01Package Change
017522014AP1986/08/26Package Change
017522013AP1985/06/17Manufacturing Change or Addition
017522012AP1986/07/23Manufacturing Change or Addition
017522011AP1984/04/02Control Supplement
017522010AP1983/06/06Manufacturing Change or Addition
017522009AP1981/07/29Control Supplement
017522008AP1982/12/03Practioner Draft Labeling
017522007AP1980/04/28Distributor
017522005AP1978/12/01Labeling Revision
017522004AP1978/04/19Package Change
017522003AP1977/01/04Distributor
017522002AP1976/06/29Manufacturing Change or Addition
017522001AP1974/10/24Control Supplement
017522000AP1974/07/19Approval