药品注册申请号：089742
申请类型：ANDA (仿制药申请)
申请人：LANNETT
申请人全名：--
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 5MG No No AB 1988/08/25 -- 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
2010/12/03 SUPPL-26（补充） Approval Labeling
2010/03/12 SUPPL-24（补充） Approval Labeling
2009/01/23 SUPPL-23（补充） Approval Labeling
2008/07/25 SUPPL-22（补充） Approval Labeling
2001/08/16 SUPPL-19（补充） Approval Manufacturing (CMC)
2001/04/12 SUPPL-18（补充） Approval Manufacturing (CMC)
1998/11/05 SUPPL-17（补充） Approval Manufacturing (CMC)
1998/01/16 SUPPL-16（补充） Approval Manufacturing (CMC)
1997/11/26 SUPPL-15（补充） Approval Manufacturing (CMC)
1997/11/26 SUPPL-14（补充） Approval Manufacturing (CMC)
1997/07/09 SUPPL-13（补充） Approval Manufacturing (CMC)
1994/08/31 SUPPL-12（补充） Approval Manufacturing (CMC)
1993/11/26 SUPPL-10（补充） Approval Manufacturing (CMC)
1993/08/27 SUPPL-11（补充） Approval Labeling
1990/01/23 SUPPL-7（补充） Approval Bioequivalence
1988/12/19 SUPPL-1（补充） Approval Bioequivalence
1988/08/25 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
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: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
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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