药品注册申请号:125387
申请类型:BLA (生物制品许可申请)
申请人:REGENERON PHARMACEUTICALS
申请人全名:--
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 EYLEA AFLIBERCEPT INJECTABLE; INJECTION 40MG/ML No None 2011/11/18 -- Prescription
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
2019/08/12 SUPPL 60 Approval Labeling STANDARD
2019/05/13 SUPPL 61 Approval Efficacy STANDARD
2018/08/16 SUPPL 58 Approval Labeling STANDARD
2018/08/16 SUPPL 56 Approval Efficacy STANDARD
2017/05/26 SUPPL 54 Approval Labeling STANDARD
2016/10/28 SUPPL 53 Approval Manufacturing (CMC) STANDARD
2016/10/24 SUPPL 52 Approval Labeling STANDARD
2016/05/24 SUPPL 51 Approval Labeling STANDARD
2015/07/30 SUPPL 36 Approval Labeling STANDARD
2015/03/25 SUPPL 48 Approval Efficacy PRIORITY
2014/10/06 SUPPL 43 Approval Efficacy STANDARD
2014/07/29 SUPPL 37 Approval Efficacy STANDARD
2014/01/27 SUPPL 23 Approval Labeling STANDARD
2013/06/07 SUPPL 20 Approval Labeling STANDARD
2013/06/07 SUPPL 15 Approval Labeling STANDARD
2012/09/21 SUPPL 4 Approval Efficacy STANDARD
2011/11/18 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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
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
与本品治疗等效的药品
本品无治疗等效药品
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药品NDC数据与药品包装、标签说明书
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