药品注册申请号:103471
申请类型:BLA (生物制品许可申请)
申请人:BAYER HEALTHCARE PHARMS
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 BETASERON INTERFERON BETA-1B VIAL; SUBCUTANEOUS 0.3 MG No None 1993/07/23 -- 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
2019/08/16 SUPPL 5195 Approval Labeling STANDARD
2018/08/31 SUPPL 5193 Approval Labeling STANDARD
2018/06/08 SUPPL 5191 Approval Labeling STANDARD
2017/05/26 SUPPL 5189 Approval Efficacy STANDARD
2016/04/19 SUPPL 5187 Approval Labeling STANDARD
2016/04/19 SUPPL 5157 Approval Labeling
2015/12/22 SUPPL 5188 Approval Labeling STANDARD
2015/09/25 SUPPL 5186 Approval Efficacy STANDARD
2014/01/28 SUPPL 5185 Approval Labeling STANDARD
2013/06/28 SUPPL 5125 Approval Manufacturing (CMC)
2012/12/11 SUPPL 5138 Approval Labeling STANDARD
2012/12/11 SUPPL 5136 Approval Labeling STANDARD
2012/12/11 SUPPL 5124 Approval Labeling STANDARD
2012/12/11 SUPPL 5120 Approval Labeling STANDARD
2012/12/11 SUPPL 5088 Approval Labeling
2012/12/11 SUPPL 5079 Approval Labeling
2012/12/11 SUPPL 5067 Approval Labeling
2012/12/11 SUPPL 5063 Approval Labeling STANDARD
2009/03/26 SUPPL 5132 Approval Supplement
2008/09/08 SUPPL 5121 Approval Supplement
2007/07/18 SUPPL 5097 Approval Supplement
2007/04/26 SUPPL 5084 Approval Supplement
2006/11/09 SUPPL 5085 Approval Supplement
2006/10/20 SUPPL 5081 Approval Efficacy STANDARD
2006/04/04 SUPPL 5082 Approval Supplement
2005/12/29 SUPPL 5075 Approval Supplement
2005/12/29 SUPPL 5071 Approval Supplement
2005/12/07 SUPPL 5069 Approval Supplement
2005/07/28 SUPPL 5066 Approval Supplement
2005/07/28 SUPPL 5065 Approval Supplement
2005/06/08 SUPPL 5060 Approval Supplement
2003/10/10 SUPPL 5032 Approval Supplement
2003/03/14 SUPPL 1039 Approval Efficacy PRIORITY
1993/07/23 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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