药品注册申请号：217975
申请类型：ANDA (仿制药申请)
申请人：UNIQUE PHARM
申请人全名：UNIQUE PHARMACEUTICAL LABORATORIES
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 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE No No AB 2023/08/21 2023/08/21 Prescription
002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE No No AB 2023/08/21 Prescription
003 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE No No AB 2023/08/21 Prescription
004 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE No No AB 2023/08/21 Prescription
005 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE No No AB 2023/08/21 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
2023/08/21 ORIG-1（原始申请） Approval 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
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:DOXEPIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 10MG 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
070791 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 1986/05/13 MYLAN PHARMS INC
071422 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Discontinued No No AB 1987/11/09 PAR PHARM
207482 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2017/06/28 AMNEAL PHARMS CO
211603 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2019/03/27 AUROBINDO PHARMA LTD
212624 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2019/09/13 AJANTA PHARMA LTD
213063 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2020/07/01 TARO
213474 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2020/07/28 CONTRACT PHARMACAL
210268 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2020/09/04 CHARTWELL RX
210675 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2020/10/16 EPIC PHARMA LLC
211619 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2021/03/09 CHEMISTRY HLTH
214908 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2021/04/01 APPCO
215076 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2021/04/21 ALEMBIC
215710 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2022/02/09 MANKIND PHARMA
215483 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2022/03/14 JUBILANT CADISTA
215113 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2022/06/24 MSN
210700 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2023/03/23 ZYDUS LIFESCIENCES
217688 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2023/06/27 MICRO LABS
217975 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2023/08/21 UNIQUE PHARM
活性成分:DOXEPIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 25MG 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
071437 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB -- PAR PHARM
070791 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No Yes AB 1986/05/13 MYLAN PHARMS INC
071422 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Discontinued No No AB 1987/11/09 PAR PHARM
207482 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2017/06/28 AMNEAL PHARMS CO
211603 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2019/03/27 AUROBINDO PHARMA LTD
212624 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2019/09/13 AJANTA PHARMA LTD
213063 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2020/07/01 TARO
213474 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2020/07/28 CONTRACT PHARMACAL
210268 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2020/09/04 CHARTWELL RX
210675 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2020/10/16 EPIC PHARMA LLC
211619 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2021/03/09 CHEMISTRY HLTH
214908 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2021/04/01 APPCO
215076 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2021/04/21 ALEMBIC
215710 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2022/02/09 MANKIND PHARMA
215483 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2022/03/14 JUBILANT CADISTA
215113 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2022/06/24 MSN
210700 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2023/03/23 ZYDUS LIFESCIENCES
217688 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2023/06/27 MICRO LABS
217975 002 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2023/08/21 UNIQUE PHARM
活性成分:DOXEPIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 50MG 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
070791 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 1986/05/13 MYLAN PHARMS INC
071422 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Discontinued No No AB 1987/11/09 PAR PHARM
207482 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2017/06/28 AMNEAL PHARMS CO
211603 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2019/03/27 AUROBINDO PHARMA LTD
212624 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2019/09/13 AJANTA PHARMA LTD
213063 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2020/07/01 TARO
213474 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2020/07/28 CONTRACT PHARMACAL
210268 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2020/09/04 CHARTWELL RX
211619 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2021/03/09 CHEMISTRY HLTH
214908 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2021/04/01 APPCO
215076 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2021/04/21 ALEMBIC
215710 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2022/02/09 MANKIND PHARMA
210675 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2022/03/03 EPIC PHARMA LLC
215483 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2022/03/14 JUBILANT CADISTA
215113 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2022/06/24 MSN
210700 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2023/03/23 ZYDUS LIFESCIENCES
217688 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2023/06/27 MICRO LABS
217975 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2023/08/21 UNIQUE PHARM
活性成分:DOXEPIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 75MG 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
070791 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 1986/05/13 MYLAN PHARMS INC
071422 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Discontinued No No AB 1987/11/09 PAR PHARM
207482 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2017/06/28 AMNEAL PHARMS CO
211603 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2019/03/27 AUROBINDO PHARMA LTD
212624 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2019/09/13 AJANTA PHARMA LTD
213063 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2020/07/01 TARO
213474 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2020/07/28 CONTRACT PHARMACAL
210268 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2020/09/04 CHARTWELL RX
211619 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2021/03/09 CHEMISTRY HLTH
214908 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2021/04/01 APPCO
215076 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2021/04/21 ALEMBIC
215710 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2022/02/09 MANKIND PHARMA
210675 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2022/03/03 EPIC PHARMA LLC
215483 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2022/03/14 JUBILANT CADISTA
215113 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2022/06/24 MSN
210700 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2023/03/23 ZYDUS LIFESCIENCES
217688 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2023/06/27 MICRO LABS
217975 004 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2023/08/21 UNIQUE PHARM
活性成分:DOXEPIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 100MG 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
070791 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No Yes AB 1986/05/13 MYLAN PHARMS INC
071422 001 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Discontinued No No AB 1987/11/09 PAR PHARM
207482 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2017/06/28 AMNEAL PHARMS CO
211603 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2019/03/27 AUROBINDO PHARMA LTD
212624 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2019/09/13 AJANTA PHARMA LTD
213063 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2020/07/01 TARO
213474 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2020/07/28 CONTRACT PHARMACAL
210268 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2020/09/04 CHARTWELL RX
210675 003 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2020/10/16 EPIC PHARMA LLC
211619 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2021/03/09 CHEMISTRY HLTH
214908 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2021/04/01 APPCO
215076 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2021/04/21 ALEMBIC
215710 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2022/02/09 MANKIND PHARMA
215483 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2022/03/14 JUBILANT CADISTA
215113 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2022/06/24 MSN
210700 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2023/03/23 ZYDUS LIFESCIENCES
217688 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2023/06/27 MICRO LABS
217975 005 ANDA DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2023/08/21 UNIQUE PHARM
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