药品注册申请号:216202
申请类型:ANDA (仿制药申请)
申请人:NOVITIUM PHARMA
申请人全名:NOVITIUM PHARMA LLC
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 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE No No AB 2022/06/13 2022/06/13 Prescription
002 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE No No AB 2022/06/13 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
2022/06/13 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
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
与本品治疗等效的药品
活性成分:PROCHLORPERAZINE MALEATE 剂型/给药途径:TABLET;ORAL 规格:EQ 5MG 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
040185 002 ANDA PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE Discontinued No No AB 1996/10/28 MYLAN
040268 001 ANDA PROCOMP PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 1998/02/27 JUBILANT CADISTA
216202 001 ANDA PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2022/06/13 NOVITIUM PHARMA
216495 001 ANDA PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2022/08/08 ZYDUS LIFESCIENCES
216595 001 ANDA PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2023/03/17 GLENMARK PHARMS LTD
217478 001 ANDA PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2023/04/04 BIONPHARMA
216598 001 ANDA PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2023/04/17 AMNEAL
218515 001 ANDA PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2024/05/09 AJANTA PHARMA LTD
活性成分:PROCHLORPERAZINE MALEATE 剂型/给药途径:TABLET;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
040185 001 ANDA PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 1996/10/28 MYLAN
040268 002 ANDA PROCOMP PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE Prescription No Yes AB 1998/02/27 JUBILANT CADISTA
216202 002 ANDA PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2022/06/13 NOVITIUM PHARMA
216495 002 ANDA PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2022/08/08 ZYDUS LIFESCIENCES
216595 002 ANDA PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2023/03/17 GLENMARK PHARMS LTD
217478 002 ANDA PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2023/04/04 BIONPHARMA
216598 002 ANDA PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2023/04/17 AMNEAL
218515 002 ANDA PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2024/05/09 AJANTA PHARMA LTD
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