药品名称RETIN-A
申请号016921产品号002
活性成分TRETINOIN市场状态停止上市
剂型或给药途径SWAB;TOPICAL规格0.05%
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构VALEANT INTERNATIONAL BARBADOS SRL
化学类型New molecular entity (NME)审评分类Priority 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
016921025APLetter2002/06/10下载
016921025APLabel2002/06/10下载
016921022APLabel2002/06/10下载
016921022APLetter2002/06/10下载
016921021APLetter2002/06/10下载
016921021APLabel2002/06/10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
016921025AP2002/06/10Labeling Revision
016921024AP1999/01/25Manufacturing Change or Addition
016921023AP1998/07/23Manufacturing Change or Addition
016921022AP2002/06/10Labeling Revision
016921021AP2002/06/10Labeling Revision
016921020AP1992/01/24Control Supplement
016921019AP1990/08/28Labeling Revision
016921017AP1986/07/22Manufacturing Change or Addition
016921016AP1983/06/06Manufacturing Change or Addition
016921015AP1981/07/28Control Supplement
016921014AP1982/12/13Practioner Draft Labeling
016921013AP1980/04/28Distributor
016921012AP1979/10/24Control Supplement
016921011AP1978/12/04Labeling Revision
016921010AP1977/01/04Distributor
016921009AP1974/09/20Control Supplement
016921000AP1971/10/20Approval