药品注册申请号：219033
申请类型：ANDA (仿制药申请)
申请人：UNICHEM
申请人全名：UNICHEM LABORATORIES LTD
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, EXTENDED RELEASE;ORAL EQ 1MG BASE No No AB 2024/11/19 2024/11/19 Prescription
002 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE No No AB 2024/11/19 Prescription
003 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE No No AB 2024/11/19 Prescription
004 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE No No AB 2024/11/19 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2024/11/19 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
无
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
无
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
无
与本品治疗等效的药品
>>>活性成分:GUANFACINE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;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
022037 001 NDA INTUNIV GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Prescription Yes No AB 2009/09/02 TAKEDA PHARMS USA
200881 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Prescription No No AB 2012/10/05 ACTAVIS ELIZABETH
201382 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Prescription No No AB 2015/06/02 TEVA PHARMS USA
201408 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Prescription No No AB 2015/06/02 TWI PHARMS
202568 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Prescription No No AB 2015/06/03 SANDOZ
205689 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Discontinued No No AB 2017/11/16 SUN PHARM
205430 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Prescription No No AB 2018/07/25 APOTEX
213428 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Prescription No No AB 2020/11/25 YICHANG HUMANWELL
217269 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Prescription No No AB 2023/08/07 ALEMBIC
217638 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Prescription No No AB 2024/06/12 FOSUN WANBANG
219033 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Prescription No No AB 2024/11/19 UNICHEM
219689 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Prescription No No AB 2025/04/15 RUBICON RESEARCH
>>>活性成分:GUANFACINE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;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
022037 002 NDA INTUNIV GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE Prescription Yes No AB 2009/09/02 TAKEDA PHARMS USA
200881 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE Prescription No No AB 2012/10/05 ACTAVIS ELIZABETH
201382 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE Prescription No No AB 2015/06/02 TEVA PHARMS USA
201408 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE Prescription No No AB 2015/06/02 TWI PHARMS
202568 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE Prescription No No AB 2015/06/03 SANDOZ
205689 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE Discontinued No No AB 2017/11/16 SUN PHARM
205430 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE Prescription No No AB 2018/07/25 APOTEX
213428 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE Prescription No No AB 2020/11/25 YICHANG HUMANWELL
217269 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE Prescription No No AB 2023/08/07 ALEMBIC
217638 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE Prescription No No AB 2024/06/12 FOSUN WANBANG
219033 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE Prescription No No AB 2024/11/19 UNICHEM
219689 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE Prescription No No AB 2025/04/15 RUBICON RESEARCH
>>>活性成分:GUANFACINE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:EQ 3MG 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
022037 003 NDA INTUNIV GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE Prescription Yes No AB 2009/09/02 TAKEDA PHARMS USA
200881 003 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE Prescription No No AB 2012/10/05 ACTAVIS ELIZABETH
201382 003 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE Prescription No No AB 2015/06/02 TEVA PHARMS USA
201408 003 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE Prescription No No AB 2015/06/02 TWI PHARMS
202568 003 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE Prescription No No AB 2015/06/03 SANDOZ
205689 003 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE Discontinued No No AB 2017/11/16 SUN PHARM
205430 003 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE Prescription No No AB 2018/07/25 APOTEX
213428 003 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE Prescription No No AB 2020/11/25 YICHANG HUMANWELL
217269 003 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE Prescription No No AB 2023/08/07 ALEMBIC
217638 003 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE Prescription No No AB 2024/06/12 FOSUN WANBANG
219033 003 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE Prescription No No AB 2024/11/19 UNICHEM
219689 003 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE Prescription No No AB 2025/04/15 RUBICON RESEARCH
>>>活性成分:GUANFACINE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;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
022037 004 NDA INTUNIV GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Prescription Yes Yes AB 2009/09/02 TAKEDA PHARMS USA
200881 004 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Prescription No No AB 2012/10/05 ACTAVIS ELIZABETH
201382 004 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Prescription No No AB 2015/06/02 TEVA PHARMS USA
201408 004 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Prescription No No AB 2015/06/02 TWI PHARMS
202568 004 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Prescription No No AB 2015/06/03 SANDOZ
205689 004 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Discontinued No No AB 2017/11/16 SUN PHARM
205430 004 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Prescription No No AB 2018/07/25 APOTEX
213428 004 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Prescription No No AB 2020/11/25 YICHANG HUMANWELL
217269 004 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Prescription No No AB 2023/08/07 ALEMBIC
217638 004 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Prescription No No AB 2024/06/12 FOSUN WANBANG
219033 004 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Prescription No No AB 2024/11/19 UNICHEM
219689 004 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Prescription No No AB 2025/04/15 RUBICON RESEARCH
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