药品注册申请号:125377
申请类型:BLA (生物制品许可申请)
申请人:BRISTOL MYERS SQUIBB
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 YERVOY IPILIMUMAB INJECTABLE; INJECTION 3MG No None 2011/03/25 -- Prescription
批准日期,审批历史,通知信,药品说明书,审评文件等信息
审批结论日期申请类型申请提交号审批结论申请内容分类审评分类(优先级;罕用药状态)通知信、审评文件、说明书、包装标签备注
2022/05/11 SUPPL 124 Approval Efficacy STANDARD
2022/02/25 SUPPL 127 Approval Labeling STANDARD
2022/02/25 SUPPL 126 Approval Labeling STANDARD
2021/05/25 SUPPL 121 Approval Efficacy STANDARD
2020/11/13 SUPPL 119 Approval Labeling STANDARD
2020/10/02 SUPPL 115 Approval Efficacy PRIORITY
2020/09/18 SUPPL 112 Approval Efficacy STANDARD
2020/08/13 SUPPL 111 Approval Labeling STANDARD
2020/06/29 SUPPL 106 Approval Labeling STANDARD
2020/05/26 SUPPL 110 Approval Efficacy PRIORITY
2020/05/15 SUPPL 109 Approval Efficacy PRIORITY
2020/03/10 SUPPL 108 Approval Efficacy PRIORITY
2019/09/20 SUPPL 104 Approval Labeling STANDARD
2019/05/08 SUPPL 102 Approval Labeling STANDARD
2018/07/10 SUPPL 96 Approval Efficacy PRIORITY
2018/04/16 SUPPL 94 Approval Efficacy PRIORITY
2018/02/08 SUPPL 93 Approval Labeling STANDARD
2017/12/13 SUPPL 91 Approval Labeling STANDARD
2017/10/20 SUPPL 86 Approval Efficacy STANDARD
2017/07/21 SUPPL 87 Approval Efficacy STANDARD
2017/03/03 SUPPL 84 Approval Labeling STANDARD
2015/10/28 SUPPL 73 Approval Efficacy STANDARD
2015/08/17 SUPPL 74 Approval Labeling STANDARD
2015/03/19 SUPPL 72 Approval Labeling STANDARD
2015/03/16 SUPPL 71 Approval REMS N/A
2013/12/05 SUPPL 55 Approval Labeling STANDARD
2013/05/22 SUPPL 44 Approval Labeling STANDARD
2012/10/26 SUPPL 33 Approval Labeling STANDARD
2012/02/16 SUPPL 16 Approval Labeling STANDARD
2011/07/28 SUPPL 8 Approval Labeling STANDARD
2011/03/25 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
更多信息
药品NDC数据与药品包装、标签说明书
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