药品注册申请号：076558
申请类型：ANDA (仿制药申请)
申请人：HIKMA
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 CIPROFLOXACIN CIPROFLOXACIN TABLET; ORAL 250MG No No None 2004/06/09 -- Prescription
002 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE No No AB 2004/06/09 Prescription
003 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE No No AB 2004/06/09 Prescription
004 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 750MG BASE No No AB 2004/06/09 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2004/06/09 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2023/08/31 SUPPL-63（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2023/08/31 SUPPL-59（补充） Approval Labeling-Package Insert STANDARD
2023/08/31 SUPPL-56（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2023/08/31 SUPPL-55（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2023/08/31 SUPPL-53（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2023/08/31 SUPPL-51（补充） Approval Labeling-Package Insert STANDARD
2023/08/31 SUPPL-49（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2018/11/07 SUPPL-46（补充） Approval Labeling-Package Insert STANDARD
2018/11/07 SUPPL-41（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2015/09/21 SUPPL-38（补充） Approval Labeling-Package Insert STANDARD
2015/09/21 SUPPL-36（补充） Approval Labeling-Package Insert STANDARD
2015/09/21 SUPPL-35（补充） Approval Labeling-Package Insert STANDARD
2014/10/31 SUPPL-22（补充） Approval Labeling-Package Insert
2012/08/15 SUPPL-34（补充） Approval Labeling-Package Insert,REMS-Modified STANDARD
2012/07/11 SUPPL-33（补充） Approval Labeling-Package Insert,Labeling-Medication Guide
2012/02/28 SUPPL-31（补充） Approval Labeling-Package Insert,Labeling-Package Insert
2011/05/12 SUPPL-27（补充） Approval Labeling-Package Insert
2011/05/08 SUPPL-28（补充） Approval Labeling-Package Insert
2009/08/24 SUPPL-21（补充） Approval Labeling
2009/08/20 SUPPL-19（补充） Approval Labeling
2009/02/04 SUPPL-4（补充） Approval Labeling
2009/01/29 SUPPL-17（补充） Approval Labeling
2008/03/16 SUPPL-14（补充） Approval Labeling
2008/02/06 SUPPL-13（补充） Approval Labeling
2007/02/09 SUPPL-12（补充） Approval Labeling
2005/11/29 SUPPL-8（补充） Approval Labeling
2005/06/29 SUPPL-7（补充） Approval Labeling
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:CIPROFLOXACIN HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 250MG 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
019537 002 NDA CIPRO CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription Yes No AB 1987/10/22 BAYER HLTHCARE
075593 003 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2004/06/09 DR REDDYS LABS LTD
075939 002 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2004/06/09 AMNEAL
076089 002 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2004/06/09 IVAX SUB TEVA PHARMS
076126 002 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2004/06/09 CARLSBAD
076558 002 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2004/06/09 HIKMA
076593 002 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2004/06/09 AIPING PHARM INC
076794 002 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2004/06/09 WATSON LABS
076639 001 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2004/09/10 UNIQUE
076896 001 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2004/11/04 CHARTWELL
077859 001 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2007/04/26 AUROBINDO PHARMA
208921 001 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2018/06/22 YILING
>>>活性成分:CIPROFLOXACIN HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 500MG 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
019537 003 NDA CIPRO CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription Yes Yes AB 1987/10/22 BAYER HLTHCARE
075593 004 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2004/06/09 DR REDDYS LABS LTD
075817 003 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2004/06/09 RISING
075939 003 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2004/06/09 AMNEAL
076089 003 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2004/06/09 IVAX SUB TEVA PHARMS
076126 003 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2004/06/09 CARLSBAD
076558 003 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2004/06/09 HIKMA
076593 003 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2004/06/09 AIPING PHARM INC
076794 003 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2004/06/09 WATSON LABS
076639 002 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2004/09/10 UNIQUE
076896 002 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2004/11/04 CHARTWELL
077859 002 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2007/04/26 AUROBINDO PHARMA
208921 002 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2018/06/22 YILING
>>>活性成分:CIPROFLOXACIN HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 750MG 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
075593 001 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 750MG BASE Prescription No No AB 2004/06/09 DR REDDYS LABS LTD
075939 004 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 750MG BASE Prescription No No AB 2004/06/09 AMNEAL
076089 004 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 750MG BASE Prescription No No AB 2004/06/09 IVAX SUB TEVA PHARMS
076126 004 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 750MG BASE Prescription No No AB 2004/06/09 CARLSBAD
076558 004 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 750MG BASE Prescription No No AB 2004/06/09 HIKMA
076593 004 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 750MG BASE Prescription No No AB 2004/06/09 AIPING PHARM INC
076794 004 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 750MG BASE Prescription No No AB 2004/06/09 WATSON LABS
076639 003 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 750MG BASE Prescription No No AB 2004/09/10 UNIQUE
076896 003 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 750MG BASE Prescription No No AB 2004/11/04 CHARTWELL
077859 003 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 750MG BASE Prescription No No AB 2007/04/26 AUROBINDO PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
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