药品名称FML FORTE
申请号019216产品号001
活性成分FLUOROMETHOLONE市场状态处方药
剂型或给药途径SUSPENSION/DROPS;OPHTHALMIC规格0.25%
治疗等效代码参比药物
批准日期1986/04/23申请机构ALLERGAN PHARMACEUTICAL
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
019216025APLetter2013/02/13下载
019216025APLabel2013/02/14下载
019216022APLabel2006/01/13下载
019216022APLetter2006/01/20下载
019216021APLabel2006/01/13下载
019216021APLetter2006/01/20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
019216025AP2013/02/12Labeling Revision
019216022AP2006/01/10Labeling Revision
019216021AP2006/01/10Package Change
019216020AP2002/09/04Control Supplement
019216019AP2002/04/12Control Supplement
019216018AP2001/12/04Manufacturing Change or Addition
019216017AP2001/09/28Manufacturing Change or Addition
019216016AP2001/04/12Manufacturing Change or Addition
019216015AP2000/10/02Manufacturing Change or Addition
019216014AP1998/09/14Control Supplement
019216013AP1997/10/09Expiration Date Change
019216012AP1998/05/08Control Supplement
019216011AP1996/12/05Control Supplement
019216010AP1994/12/22Control Supplement
019216009AP1995/08/03Control Supplement
019216008AP1993/09/20Control Supplement
019216007AP1992/05/21Labeling Revision
019216006AP1990/02/27Manufacturing Change or Addition
019216005AP1989/10/13Manufacturing Change or Addition
019216004AP1989/10/17Control Supplement
019216003AP1990/05/18Labeling Revision
019216002AP1986/08/28Package Change
019216001AP1986/11/05Control Supplement
019216000AP1986/04/23Approval