药品名称RETIN-A MICRO
申请号020475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0.1%
治疗等效代码AB参比药物
批准日期1997/02/07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
59551092016/09/21YU-134PDF格式
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
020475021APLabel2014/01/31下载
020475021APReview2015/08/25下载
020475008APLetter2002/05/10下载
020475008APLabel2002/05/10下载
020475000APReview1997/02/07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
020475024AP2014/08/21Manufacturing Change or Addition
020475023AP2014/01/29Manufacturing Change or Addition
020475021AP2014/01/28Manufacturing Change or Addition
020475020AP2013/01/08Manufacturing Change or Addition
020475008AP2002/05/10New Dosage Regimen
020475007AP2001/03/20Package Change
020475006AP2000/04/27Labeling Revision
020475005AP2000/04/05Control Supplement
020475004AP1999/11/10Manufacturing Change or Addition
020475003AP1999/04/23Manufacturing Change or Addition
020475002AP1998/11/13Control Supplement
020475001AP1998/11/13Manufacturing Change or Addition
020475000AP1997/02/07Approval