药品注册申请号:075109
申请类型:ANDA (仿制药申请)
申请人:AMNEAL PHARM
申请人全名:AMNEAL PHARMACEUTICAL
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 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE No No AB 1998/11/25 1998/11/25 Prescription
002 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE No Yes AB 1998/11/25 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
2014/02/19 SUPPL-5(补充) Approval Manufacturing (CMC)
2002/11/04 SUPPL-3(补充) Approval Labeling
2001/06/22 SUPPL-1(补充) Approval Manufacturing (CMC)
1998/11/25 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:GUANFACINE HYDROCHLORIDE 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
074145 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 1995/10/17 WATSON LABS
074796 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 1997/01/27 AUROBINDO PHARMA USA
074673 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 1997/02/28 EPIC PHARMA LLC
075109 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 1998/11/25 AMNEAL PHARM
214689 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2021/03/03 UNICHEM
216399 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2022/06/08 TWI PHARMS
217293 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2023/04/27 AJANTA PHARMA LTD
216828 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2023/10/05 I 3 PHARMS
216762 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2023/10/17 RUBICON
218326 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2024/02/23 XIROMED
活性成分:GUANFACINE HYDROCHLORIDE 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
074145 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 1995/10/17 WATSON LABS
074796 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 1997/01/27 AUROBINDO PHARMA USA
074673 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 1997/02/28 EPIC PHARMA LLC
075109 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No Yes AB 1998/11/25 AMNEAL PHARM
214689 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2021/03/03 UNICHEM
216399 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2022/06/08 TWI PHARMS
217293 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2023/04/27 AJANTA PHARMA LTD
216828 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2023/10/05 I 3 PHARMS
216762 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2023/10/17 RUBICON
218326 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2024/02/23 XIROMED
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