药品名称MAXIDEX
申请号013422产品号001
活性成分DEXAMETHASONE市场状态处方药
剂型或给药途径SUSPENSION/DROPS;OPHTHALMIC规格0.1%
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ALCON LABORATORIES INC
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
013422035APLabel2003/05/28下载
013422035APLetter2003/05/29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
013422043AP2016/08/05Manufacturing Change or Addition
013422042AP2016/03/10Manufacturing Change or Addition
013422041AP2015/04/07Manufacturing Change or Addition
013422040AP2013/09/27Manufacturing Change or Addition
013422035AP2003/04/17Labeling Revision
013422034AP2002/12/11Control Supplement
013422033AP2002/12/04Control Supplement
013422032AP2000/02/04Manufacturing Change or Addition
013422031AP1999/08/17Control Supplement
013422030AP1999/04/07Manufacturing Change or Addition
013422029AP1999/02/05Manufacturing Change or Addition
013422028AP1999/03/11Control Supplement
013422027AP1998/08/04Control Supplement
013422025AP1996/10/17Control Supplement
013422024AP1996/09/26Labeling Revision
013422023AP1996/03/18Control Supplement
013422022AP1995/11/01Control Supplement
013422021AP1995/11/01Control Supplement
013422020AP1995/06/14Package Change
013422019AP1989/11/28Control Supplement
013422018AP1989/12/06Manufacturing Change or Addition
013422017AP1988/03/02Manufacturing Change or Addition
013422016AP1984/03/21Control Supplement
013422015AP1983/08/05Manufacturing Change or Addition
013422014AP1984/08/08Control Supplement
013422013AP1981/08/05Control Supplement
013422011AP1979/07/06Control Supplement
013422010AP1979/07/06Labeling Revision
013422004AP1990/05/31Package Change
013422000AP1962/06/20Approval