药品名称RETIN-A
申请号017579产品号002
活性成分TRETINOIN市场状态处方药
剂型或给药途径GEL;TOPICAL规格0.025%
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
017579023APLabel2002/06/10下载
017579023APLetter2002/06/10下载
017579020APLetter2002/06/10下载
017579020APLabel2002/06/10下载
017579018APLabel2002/06/10下载
017579018APLetter2002/06/10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
017579034AP2016/10/06Manufacturing Change or Addition
017579032AP2013/05/14Manufacturing Change or Addition
017579024AP2001/03/20Package Change
017579023AP2002/06/10Labeling Revision
017579022AP1999/01/25Manufacturing Change or Addition
017579021AP1998/07/23Manufacturing Change or Addition
017579020AP2002/06/10Labeling Revision
017579018AP2002/06/10Labeling Revision
017579016AP1992/01/31Control Supplement
017579015AP1990/07/03Control Supplement
017579014AP1990/08/28Labeling Revision
017579013AP1990/08/28Labeling Revision
017579012AP1989/12/01Package Change
017579010AP1985/06/11Manufacturing Change or Addition
017579009AP1986/07/23Manufacturing Change or Addition
017579008AP1982/11/30Final Printed Labeling - MarkIV
017579007AP1981/07/29Control Supplement
017579005AP1980/04/28Distributor
017579004AP1979/10/23Control Supplement
017579003AP1978/12/01Labeling Revision
017579002AP1977/06/14Package Change
017579001AP1977/01/04Distributor
017579000AP1975/04/18Approval