药品注册申请号:075474
申请类型:ANDA (仿制药申请)
申请人:UNITED RES LABS
申请人全名:UNITED RESEARCH LABORATORIES LLC
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 BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 5MG No No AB 2002/10/25 2002/10/25 Prescription
002 BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 10MG No No AB 2002/10/25 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
2005/01/04 SUPPL-7(补充) Approval Labeling
2002/10/25 ORIG-1(原始申请) Approval
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
活性成分:BISOPROLOL FUMARATE 剂型/给药途径:TABLET;ORAL 规格:5MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
075643 001 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 5MG Prescription No No AB 2000/11/16 RUBICON
075474 001 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 5MG Prescription No No AB 2002/10/25 UNITED RES LABS
077910 001 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 5MG Prescription No No AB 2006/12/27 AUROBINDO PHARMA
078635 001 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 5MG Prescription No No AB 2009/08/18 UNICHEM
204891 001 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 5MG Prescription No No AB 2017/01/11 ALEMBIC
215563 001 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 5MG Prescription No No AB 2021/10/29 NOVITIUM PHARMA
215680 001 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 5MG Prescription No No AB 2022/07/25 ZYDUS LIFESCIENCES
217368 001 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 5MG Prescription No No AB 2023/07/14 PRINSTON INC
217617 001 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 5MG Prescription No No AB 2024/01/18 HARMAN FINOCHEM
活性成分:BISOPROLOL FUMARATE 剂型/给药途径:TABLET;ORAL 规格:10MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
075643 002 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 10MG Prescription No No AB 2000/11/16 RUBICON
075474 002 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 10MG Prescription No No AB 2002/10/25 UNITED RES LABS
077910 002 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 10MG Prescription No No AB 2006/12/27 AUROBINDO PHARMA
078635 002 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 10MG Prescription No Yes AB 2009/08/18 UNICHEM
204891 002 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 10MG Prescription No No AB 2017/01/11 ALEMBIC
215563 002 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 10MG Prescription No No AB 2021/10/29 NOVITIUM PHARMA
215680 002 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 10MG Prescription No No AB 2022/07/25 ZYDUS LIFESCIENCES
217368 002 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 10MG Prescription No No AB 2023/07/14 PRINSTON INC
217617 002 ANDA BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 10MG Prescription No No AB 2024/01/18 HARMAN FINOCHEM
更多信息
药品NDC数据与药品包装、标签说明书
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