药品注册申请号：214552
申请类型：ANDA (仿制药申请)
申请人：ZYDUS LIFESCIENCES
申请人全名：ZYDUS LIFESCIENCES GLOBAL FZE
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 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG No No AB 2021/05/27 2021/05/27 Prescription
002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG No No AB 2021/05/27 Prescription
003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG No No AB 2021/05/27 Prescription
004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2021/05/27 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
2021/05/27 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:FLUPHENAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:1MG 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
089740 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB -- LANNETT
089804 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Discontinued No No AB 1988/08/12 PRASCO
089743 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 1988/08/25 LANNETT CO INC
213647 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2020/07/09 AMNEAL
214534 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2021/01/07 DR REDDYS
214674 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2021/03/01 NOVITIUM PHARMA
214552 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2021/05/27 ZYDUS LIFESCIENCES
215141 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2021/10/20 CHARTWELL RX
215674 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2022/04/14 TARO
216649 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2022/07/15 APOTEX
213784 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2022/10/24 UPSHER SMITH LABS
216891 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2022/11/15 SANDOZ
215848 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2022/12/14 TWI PHARMS
217410 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2023/01/05 AJANTA PHARMA LTD
218055 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2023/08/18 AUROBINDO PHARMA LTD
217189 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2023/09/11 MSN
216350 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2023/11/06 GLENMARK PHARMS LTD
217094 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Discontinued No No AB 2024/01/22 TORRENT
218283 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2024/06/07 RISING
218173 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2024/07/23 ALEMBIC
活性成分:FLUPHENAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:2.5MG 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
089741 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB -- LANNETT
089804 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Discontinued No No AB 1988/08/12 PRASCO
089743 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 1988/08/25 LANNETT CO INC
213647 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2020/07/09 AMNEAL
214534 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2021/01/07 DR REDDYS
214674 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2021/03/01 NOVITIUM PHARMA
214552 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2021/05/27 ZYDUS LIFESCIENCES
215141 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2021/10/20 CHARTWELL RX
215848 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2022/04/01 TWI PHARMS
215674 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2022/04/14 TARO
216649 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2022/07/15 APOTEX
213784 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2022/10/24 UPSHER SMITH LABS
216891 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2022/11/15 SANDOZ
217410 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2023/01/05 AJANTA PHARMA LTD
218055 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2023/08/18 AUROBINDO PHARMA LTD
217189 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2023/09/11 MSN
216350 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2023/11/06 GLENMARK PHARMS LTD
217094 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Discontinued No No AB 2024/01/22 TORRENT
218283 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2024/06/07 RISING
218173 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2024/07/23 ALEMBIC
活性成分:FLUPHENAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:5MG 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
089585 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB -- SANDOZ
089742 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB -- LANNETT
089804 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Discontinued No No AB 1988/08/12 PRASCO
089743 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No Yes AB 1988/08/25 LANNETT CO INC
213647 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2020/07/09 AMNEAL
214534 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2021/01/07 DR REDDYS
214674 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2021/03/01 NOVITIUM PHARMA
214552 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2021/05/27 ZYDUS LIFESCIENCES
215141 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2021/10/20 CHARTWELL RX
215848 002 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2022/04/01 TWI PHARMS
215674 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2022/04/14 TARO
216649 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2022/07/15 APOTEX
213784 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2022/10/24 UPSHER SMITH LABS
216891 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2022/11/15 SANDOZ
217410 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2023/01/05 AJANTA PHARMA LTD
218055 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2023/08/18 AUROBINDO PHARMA LTD
217189 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2023/09/11 MSN
216350 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2023/11/06 GLENMARK PHARMS LTD
217094 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Discontinued No No AB 2024/01/22 TORRENT
218283 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2024/06/07 RISING
218173 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2024/07/23 ALEMBIC
活性成分:FLUPHENAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 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
089804 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 1988/08/12 PRASCO
089743 001 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1988/08/25 LANNETT CO INC
213647 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2020/07/09 AMNEAL
214534 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/01/07 DR REDDYS
214674 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/03/01 NOVITIUM PHARMA
214552 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/05/27 ZYDUS LIFESCIENCES
215141 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/10/20 CHARTWELL RX
215848 003 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2022/04/01 TWI PHARMS
215674 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2022/04/14 TARO
216649 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2022/07/15 APOTEX
213784 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2022/10/24 UPSHER SMITH LABS
216891 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2022/11/15 SANDOZ
217410 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2023/01/05 AJANTA PHARMA LTD
218055 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2023/08/18 AUROBINDO PHARMA LTD
217189 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2023/09/11 MSN
216350 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2023/11/06 GLENMARK PHARMS LTD
217094 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 2024/01/22 TORRENT
218283 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2024/06/07 RISING
218173 004 ANDA FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2024/07/23 ALEMBIC
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