药品名称NASALCROM
申请号020463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剂型或给药途径SPRAY, METERED;NASAL规格5.2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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
批准日期1997/01/03申请机构BLACKSMITH BRANDS INC
化学类型OTC (over-the-counter) switch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
020463008APLetter2004/07/21下载
020463002APLetter2001/03/27下载
020463002APReview2001/03/27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
020463008AP2004/07/15Labeling Revision
020463005AP2002/11/27Control Supplement
020463004AP2002/11/27Manufacturing Change or Addition
020463003AP2000/06/12Control Supplement
020463002AP2001/03/27Patient Population Altered
020463001AP1998/11/04Package Change
020463000AP1997/01/03Approval