药品注册申请号:103705
申请类型:BLA (生物制品许可申请)
申请人:GENENTECH
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 RITUXAN RITUXIMAB SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) No No None 1997/11/26 -- Prescription
002 RITUXAN RITUXIMAB SOLUTION;INTRAVENOUS 500MG/50ML (10MG/ML) No No None -- Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2021/12/17 SUPPL-5467(补充) Approval Labeling STANDARD
2021/12/02 SUPPL-5465(补充) Approval Efficacy PRIORITY ;Orphan
2021/06/30 SUPPL-5464(补充) Approval Labeling STANDARD
2020/08/28 SUPPL-5460(补充) Approval Efficacy STANDARD
2020/03/13 SUPPL-5458(补充) Approval Labeling STANDARD
2020/01/23 SUPPL-5461(补充) Approval Labeling STANDARD
2019/11/25 SUPPL-5459(补充) Approval Labeling STANDARD
2019/09/27 SUPPL-5457(补充) Approval Efficacy PRIORITY ;Orphan
2019/01/25 SUPPL-5454(补充) Approval Efficacy STANDARD ;Orphan
2018/10/18 SUPPL-5451(补充) Approval Efficacy STANDARD ;Orphan
2018/06/07 SUPPL-5450(补充) Approval Efficacy PRIORITY ;Orphan
2018/04/03 SUPPL-5453(补充) Approval Labeling STANDARD ;Orphan
2014/08/12 SUPPL-5432(补充) Approval Labeling STANDARD
2013/09/24 SUPPL-5414(补充) Approval Labeling STANDARD
2013/05/09 SUPPL-5409(补充) Approval Labeling STANDARD
2012/10/19 SUPPL-5388(补充) Approval Labeling
2012/10/19 SUPPL-5367(补充) Approval Efficacy STANDARD ;Orphan
2012/07/13 SUPPL-5373(补充) Approval Labeling STANDARD
2012/04/13 SUPPL-5370(补充) Approval Labeling STANDARD
2012/02/17 SUPPL-5362(补充) Approval Labeling STANDARD
2011/04/19 SUPPL-5344(补充) Approval Efficacy PRIORITY ;Orphan
2011/01/28 SUPPL-5332(补充) Approval Efficacy STANDARD ;Orphan
2011/01/06 SUPPL-5343(补充) Approval Labeling STANDARD
2010/10/06 SUPPL-5334(补充) Approval Labeling STANDARD
2010/02/18 SUPPL-5312(补充) Approval Efficacy PRIORITY ;Orphan
2010/02/18 SUPPL-5311(补充) Approval Efficacy PRIORITY ;Orphan
2009/10/16 SUPPL-5299(补充) Approval Efficacy STANDARD
2009/09/22 SUPPL-5310(补充) Approval Labeling STANDARD
2008/09/08 SUPPL-5291(补充) Approval Supplement
2008/09/08 SUPPL-5285(补充) Approval Labeling STANDARD
2008/01/25 SUPPL-5256(补充) Approval Efficacy STANDARD
2008/01/24 SUPPL-5263(补充) Approval Labeling STANDARD
2007/09/28 SUPPL-5262(补充) Approval Labeling STANDARD
2007/08/22 SUPPL-5259(补充) Approval Labeling STANDARD
2007/02/21 SUPPL-5247(补充) Approval Labeling STANDARD
2006/09/29 SUPPL-5231(补充) Approval Efficacy PRIORITY ;Orphan
2006/09/29 SUPPL-5230(补充) Approval Efficacy PRIORITY ;Orphan
2006/02/28 SUPPL-5211(补充) Approval Efficacy PRIORITY
2006/02/10 SUPPL-5209(补充) Approval Efficacy PRIORITY ;Orphan
1997/11/26 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY ;Orphan
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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