OPTICROM(CROMOLYN SODIUM) - 美国FDA药品数据库

药品名称	OPTICROM
申请号	018155	产品号	001
活性成分	CROMOLYN SODIUM	市场状态	停止上市
剂型或给药途径	SOLUTION/DROPS;OPHTHALMIC	规格	4% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
治疗等效代码		参比药物	否
批准日期	1984/10/03	申请机构	ALLERGAN INC
化学类型	New dosage form	审评分类	Standard review drug
罕用药/孤儿药	是

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
无
历史专利信息
无

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
018155	026	AP	2002/04/12	Control Supplement
018155	025	AP	2001/12/04	Manufacturing Change or Addition
018155	024	AP	2001/04/12	Manufacturing Change or Addition
018155	023	AP	2001/07/24	Manufacturing Change or Addition
018155	022	AP	2001/02/13	Labeling Revision
018155	021	AP	2000/10/02	Manufacturing Change or Addition
018155	020	AP	1998/03/03	Manufacturing Change or Addition
018155	018	AP	1993/06/11	New Dosage Regimen
018155	017	AP	1992/07/22	Package Change
018155	016	AP	1992/10/13	Manufacturing Change or Addition
018155	013	AP	1990/02/09	Manufacturing Change or Addition
018155	012	AP	1989/04/04	Package Change
018155	011	AP	1987/09/23	Control Supplement
018155	010	AP	1987/04/23	Expiration Date Change
018155	008	AP	1986/10/24	Manufacturing Change or Addition
018155	007	AP	1987/03/12	Package Change
018155	006	AP	1986/12/02	Package Change
018155	005	AP	1986/06/20	Package Change
018155	004	AP	1985/06/28	Package Change
018155	003	AP	1985/12/23	Manufacturing Change or Addition
018155	002	AP	1985/07/24	Control Supplement
018155	001	AP	1985/01/16	Control Supplement
018155	000	AP	1984/10/03	Approval