药品注册申请号:021664
申请类型:NDA (新药申请)
申请人:BAUSCH AND LOMB INC
申请人全名:BAUSCH AND LOMB INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 XIBROM BROMFENAC SODIUM SOLUTION/DROPS;OPHTHALMIC EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 2005/03/24 2005/03/24 Discontinued
002 BROMDAY BROMFENAC SODIUM SOLUTION/DROPS;OPHTHALMIC EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 2010/10/16 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2014/12/11 SUPPL 20 Approval Manufacturing (CMC) STANDARD
2014/01/27 SUPPL 19 Approval Labeling STANDARD
2014/01/27 SUPPL 14 Approval Labeling UNKNOWN
2010/10/16 SUPPL 13 Approval Efficacy STANDARD
2009/06/02 SUPPL 10 Approval Labeling STANDARD
2006/01/27 SUPPL 1 Approval Efficacy UNKNOWN
2005/03/24 ORIG 1 Approval Type 3 - New Dosage Form STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
001 4910225 2009/01/24 Y U-810 PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
001 I-485 2009/01/27**本条是由Drugfuture回溯的历史信息**
NP 2008/03/24**本条是由Drugfuture回溯的历史信息**
002 NP 2013/10/16**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
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