药品注册申请号:021287
申请类型:NDA (新药申请)
申请人:CONCORDIA
申请人全名:CONCORDIA PHARMACEUTICALS INC
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 UROXATRAL ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Yes Yes AB 2003/06/12 2003/06/12 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
2020/05/22 SUPPL-24(补充) Approval Labeling STANDARD
2018/05/14 SUPPL-21(补充) Approval Labeling STANDARD
2016/03/23 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
2014/04/21 SUPPL-18(补充) Approval Labeling STANDARD
2013/05/30 SUPPL-17(补充) Approval Labeling STANDARD
2010/12/15 SUPPL-16(补充) Approval Efficacy PRIORITY
2010/04/09 SUPPL-14(补充) Approval Labeling UNKNOWN
2009/05/20 SUPPL-13(补充) Approval Labeling STANDARD
2008/09/18 SUPPL-11(补充) Approval Labeling STANDARD
2008/05/06 SUPPL-9(补充) Approval Labeling STANDARD
2007/03/29 SUPPL-8(补充) Approval Labeling STANDARD
2006/11/16 SUPPL-7(补充) Approval Labeling STANDARD
2006/03/17 SUPPL-5(补充) Approval Labeling STANDARD
2003/07/15 SUPPL-1(补充) Approval Labeling STANDARD
2003/06/12 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity STANDARD
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
001 4661491 2011/01/18 U-706 PDF格式**本条是由Drugfuture回溯的历史信息**
6149940 2017/08/22 PDF格式**本条是由Drugfuture回溯的历史信息**
6149940*PED 2018/02/22 PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 M-97 2013/12/15**本条是由Drugfuture回溯的历史信息**
NCE 2008/06/12**本条是由Drugfuture回溯的历史信息**
PED 2014/06/15**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:ALFUZOSIN HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;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
021287 001 NDA UROXATRAL ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Prescription Yes Yes AB 2003/06/12 CONCORDIA
079013 001 ANDA ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2011/07/18 APOTEX INC
079057 001 ANDA ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2011/07/18 SUN PHARM
090284 001 ANDA ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2012/01/17 INVAGEN PHARMS
079060 001 ANDA ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2012/08/30 AUROBINDO PHARMA LTD
203192 001 ANDA ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2016/01/28 UNICHEM
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