药品名称RETIN-A
申请号017340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0.1%
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 PHARMACEUTICALS NORTH AMERICA LLC
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
017340036APLabel2002/06/10下载
017340036APLetter2002/06/10下载
017340033APLetter2002/06/10下载
017340033APLabel2002/06/10下载
017340032APLabel2002/06/10下载
017340032APLetter2002/06/10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
017340048AP2016/05/13Manufacturing Change or Addition
017340047AP2015/12/17Manufacturing Change or Addition
017340046AP2013/01/08Manufacturing Change or Addition
017340038AP2002/12/06Manufacturing Change or Addition
017340037AP2001/03/20Package Change
017340036AP2002/06/10Labeling Revision
017340035AP1999/01/25Manufacturing Change or Addition
017340034AP1998/07/23Manufacturing Change or Addition
017340033AP2002/06/10Labeling Revision
017340032AP2002/06/10Labeling Revision
017340030AP1992/01/24Control Supplement
017340029AP1990/07/03Control Supplement
017340028AP1990/08/28Labeling Revision
017340027AP1990/08/28Labeling Revision
017340026AP1989/12/01Package Change
017340025AP1989/04/12Labeling Revision
017340023AP1986/08/26Package Change
017340022AP1985/06/11Manufacturing Change or Addition
017340021AP1986/07/24Manufacturing Change or Addition
017340020AP1984/03/30Control Supplement
017340019AP1983/06/06Manufacturing Change or Addition
017340018AP1981/07/28Control Supplement
017340017AP1982/12/13Distributor
017340015AP1978/12/04Labeling Revision
017340014AP1977/01/04Distributor
017340013AP1976/06/30Manufacturing Change or Addition
017340010AP1974/08/27Control Supplement
017340009AP1974/04/15Supplement
017340007AP1974/04/15Supplement
017340000AP1973/01/26Approval