药品名称RETIN-A
申请号017955产品号001
活性成分TRETINOIN市场状态处方药
剂型或给药途径GEL;TOPICAL规格0.01%
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构VALEANT INTERNATIONAL BARBADOS SRL
化学类型New dosage form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
017955023APLetter2002/06/10下载
017955023APLabel2002/06/10下载
017955020APLabel2002/06/10下载
017955020APLetter2002/06/10下载
017955019APLetter2002/06/10下载
017955019APLabel2002/06/10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
017955034AP2016/10/06Manufacturing Change or Addition
017955031AP2013/02/01Manufacturing Change or Addition
017955024AP2001/03/20Package Change
017955023AP2002/06/10Labeling Revision
017955022AP1999/01/25Manufacturing Change or Addition
017955021AP1998/07/23Manufacturing Change or Addition
017955020AP2002/06/10Labeling Revision
017955019AP2002/06/10Labeling Revision
017955016AP1992/01/24Control Supplement
017955014AP1990/07/03Control Supplement
017955013AP1990/08/28Labeling Revision
017955012AP1990/08/28Labeling Revision
017955011AP1989/12/01Package Change
017955009AP1985/06/11Manufacturing Change or Addition
017955008AP1986/07/23Manufacturing Change or Addition
017955007AP1983/06/06Manufacturing Change or Addition
017955005AP1981/07/29Control Supplement
017955004AP1982/12/06Practioner Draft Labeling
017955003AP1980/04/28Distributor
017955002AP1979/11/05Control Supplement
017955001AP1979/07/03Manufacturing Change or Addition
017955000AP1978/10/17Approval