药品注册申请号：022037
申请类型：NDA (新药申请)
申请人：TAKEDA PHARMS USA
申请人全名：TAKEDA 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 INTUNIV GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Yes No AB 2009/09/02 2009/09/02 Prescription
002 INTUNIV GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE Yes No AB 2009/09/02 Prescription
003 INTUNIV GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE Yes No AB 2009/09/02 Prescription
004 INTUNIV GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Yes Yes AB 2009/09/02 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
2019/12/27 SUPPL-19（补充） Approval Labeling STANDARD
2019/04/30 SUPPL-18（补充） Approval Labeling STANDARD
2018/03/07 SUPPL-16（补充） Approval Labeling STANDARD
2017/11/27 SUPPL-14（补充） Approval Labeling STANDARD
2016/07/07 SUPPL-13（补充） Approval Labeling STANDARD
2015/03/18 SUPPL-11（补充） Approval Efficacy STANDARD
2014/11/19 SUPPL-10（补充） Approval Efficacy PRIORITY
2013/08/23 SUPPL-9（补充） Approval Labeling STANDARD
2013/02/20 SUPPL-8（补充） Approval Efficacy STANDARD
2011/06/08 SUPPL-6（补充） Approval Labeling UNKNOWN
2011/02/25 SUPPL-2（补充） Approval Efficacy STANDARD
2009/09/02 ORIG-1（原始申请） Approval Type 3 - New Dosage Form 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 5854290 2015/09/21 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
6287599 2020/12/20 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6287599*PED 2021/06/20 PDF格式**本条是由Drugfuture回溯的历史信息**
6811794 2022/07/04 Y U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
6811794*PED 2023/01/04 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5854290 2015/09/21 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
6287599 2020/12/20 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6287599*PED 2021/06/20 PDF格式**本条是由Drugfuture回溯的历史信息**
6811794 2022/07/04 Y U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
6811794*PED 2023/01/04 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5854290 2015/09/21 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
6287599 2020/12/20 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6287599*PED 2021/06/20 PDF格式**本条是由Drugfuture回溯的历史信息**
6811794 2022/07/04 Y U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
6811794*PED 2023/01/04 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5854290 2015/09/21 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
6287599 2020/12/20 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6287599*PED 2021/06/20 PDF格式**本条是由Drugfuture回溯的历史信息**
6811794 2022/07/04 Y U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
6811794*PED 2023/01/04 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 D-145 2017/11/19**本条是由Drugfuture回溯的历史信息**
I-635 2014/02/25**本条是由Drugfuture回溯的历史信息**
M-154 2018/03/18**本条是由Drugfuture回溯的历史信息**
PED 2018/05/19**本条是由Drugfuture回溯的历史信息**
002 D-145 2017/11/19**本条是由Drugfuture回溯的历史信息**
I-635 2014/02/25**本条是由Drugfuture回溯的历史信息**
M-154 2018/03/18**本条是由Drugfuture回溯的历史信息**
PED 2018/05/19**本条是由Drugfuture回溯的历史信息**
003 D-145 2017/11/19**本条是由Drugfuture回溯的历史信息**
I-635 2014/02/25**本条是由Drugfuture回溯的历史信息**
M-154 2018/03/18**本条是由Drugfuture回溯的历史信息**
PED 2018/05/19**本条是由Drugfuture回溯的历史信息**
004 D-145 2017/11/19**本条是由Drugfuture回溯的历史信息**
I-635 2014/02/25**本条是由Drugfuture回溯的历史信息**
M-154 2018/03/18**本条是由Drugfuture回溯的历史信息**
PED 2018/05/19**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: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 Prescription 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 WANBANG BIOPHARMS
219033 001 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Prescription No No AB 2024/11/19 UNICHEM
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 Prescription 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 WANBANG BIOPHARMS
219033 002 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE Prescription No No AB 2024/11/19 UNICHEM
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 Prescription 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 WANBANG BIOPHARMS
219033 003 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE Prescription No No AB 2024/11/19 UNICHEM
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 Prescription 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 WANBANG BIOPHARMS
219033 004 ANDA GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Prescription No No AB 2024/11/19 UNICHEM
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