药品注册申请号:207285
申请类型:ANDA (仿制药申请)
申请人:CHARTWELL RX
申请人全名:CHARTWELL RX SCIENCES 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 MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 400MG BASE No No AB 2017/02/13 2017/02/13 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
2017/02/13 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:MOXIFLOXACIN HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 400MG 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
077437 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2014/02/18 TEVA PHARMS USA
202632 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2014/03/04 AUROBINDO PHARMA LTD
076938 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 400MG BASE Prescription No Yes AB 2014/03/04 DR REDDYS
200160 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 400MG BASE Discontinued No No AB 2014/04/03 TORRENT
205348 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2016/01/14 CROSSMEDIKA SA
207285 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2017/02/13 CHARTWELL RX
208682 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2017/09/22 MSN
204836 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2023/03/02 HETERO LABS LTD V
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