药品注册申请号:075536
申请类型:ANDA (仿制药申请)
申请人:TEVA
申请人全名:TEVA PHARMACEUTICALS USA 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 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 1MG BASE No No AB 2000/10/18 2000/10/18 Prescription
002 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 2MG BASE No No AB 2000/10/18 Prescription
003 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 4MG BASE No No AB 2000/10/18 Prescription
004 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 8MG BASE No No AB 2000/10/18 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
2017/09/29 SUPPL-18(补充) Approval Labeling STANDARD
2017/02/21 SUPPL-19(补充) Approval Labeling STANDARD
2013/04/26 SUPPL-10(补充) Approval Labeling
2010/06/15 SUPPL-9(补充) Approval Labeling
2006/12/15 SUPPL-7(补充) Approval Labeling
2004/03/26 SUPPL-6(补充) Approval Labeling
2003/07/14 SUPPL-5(补充) Approval Labeling
2002/06/17 SUPPL-3(补充) Approval Manufacturing (CMC)
2001/12/26 SUPPL-2(补充) Approval Manufacturing (CMC)
2001/04/25 SUPPL-1(补充) Approval Labeling
2000/10/18 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:DOXAZOSIN MESYLATE 剂型/给药途径:TABLET;ORAL 规格:EQ 1MG BASE 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
019668 001 NDA CARDURA DOXAZOSIN MESYLATE TABLET;ORAL EQ 1MG BASE Prescription Yes Yes AB 1990/11/02 VIATRIS
075536 001 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2000/10/18 TEVA
075580 001 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2000/10/18 APOTEX
075509 001 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2000/10/19 AUROBINDO PHARMA USA
202824 001 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2014/06/11 ACCORD HLTHCARE
208719 001 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2017/07/07 ZYDUS PHARMS
205210 001 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2018/02/13 HERITAGE PHARMA
209013 001 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2018/04/17 UPSHER SMITH LABS
212727 001 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2022/03/15 RISING
212329 001 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2024/01/10 UNICHEM
活性成分:DOXAZOSIN MESYLATE 剂型/给药途径:TABLET;ORAL 规格:EQ 2MG BASE 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
019668 002 NDA CARDURA DOXAZOSIN MESYLATE TABLET;ORAL EQ 2MG BASE Prescription Yes No AB 1990/11/02 VIATRIS
075536 002 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2000/10/18 TEVA
075580 002 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2000/10/18 APOTEX
075509 002 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2000/10/19 AUROBINDO PHARMA USA
202824 002 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2014/06/11 ACCORD HLTHCARE
208719 002 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2017/07/07 ZYDUS PHARMS
205210 002 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2018/02/13 HERITAGE PHARMA
209013 002 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2018/04/17 UPSHER SMITH LABS
212727 002 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2022/03/15 RISING
212329 002 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2024/01/10 UNICHEM
活性成分:DOXAZOSIN MESYLATE 剂型/给药途径:TABLET;ORAL 规格:EQ 4MG BASE 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
019668 003 NDA CARDURA DOXAZOSIN MESYLATE TABLET;ORAL EQ 4MG BASE Prescription Yes No AB 1990/11/02 VIATRIS
075536 003 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2000/10/18 TEVA
075580 003 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2000/10/18 APOTEX
075509 003 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2000/10/19 AUROBINDO PHARMA USA
202824 003 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2014/06/11 ACCORD HLTHCARE
208719 003 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2017/07/07 ZYDUS PHARMS
205210 003 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2018/02/13 HERITAGE PHARMA
209013 003 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2018/04/17 UPSHER SMITH LABS
212727 003 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2022/03/15 RISING
212329 003 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2024/01/10 UNICHEM
活性成分:DOXAZOSIN MESYLATE 剂型/给药途径:TABLET;ORAL 规格:EQ 8MG BASE 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
019668 004 NDA CARDURA DOXAZOSIN MESYLATE TABLET;ORAL EQ 8MG BASE Prescription Yes No AB 1990/11/02 VIATRIS
075536 004 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 8MG BASE Prescription No No AB 2000/10/18 TEVA
075580 004 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 8MG BASE Prescription No No AB 2000/10/18 APOTEX
075509 004 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 8MG BASE Prescription No No AB 2000/10/19 AUROBINDO PHARMA USA
202824 004 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 8MG BASE Prescription No No AB 2014/06/11 ACCORD HLTHCARE
208719 004 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 8MG BASE Prescription No No AB 2017/07/07 ZYDUS PHARMS
205210 004 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 8MG BASE Prescription No No AB 2018/02/13 HERITAGE PHARMA
209013 004 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 8MG BASE Prescription No No AB 2018/04/17 UPSHER SMITH LABS
212727 004 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 8MG BASE Prescription No No AB 2022/03/15 RISING
212329 004 ANDA DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 8MG BASE Prescription No No AB 2024/01/10 UNICHEM
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