药品注册申请号：076639
申请类型：ANDA (仿制药申请)
申请人：UNIQUE
申请人全名：UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD
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 HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE No No AB 2004/09/10 2004/09/10 Prescription
002 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE No No AB 2004/09/10 Prescription
003 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 750MG BASE No No AB 2004/09/10 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
2022/12/19 SUPPL-30（补充） Approval Labeling STANDARD
2022/12/19 SUPPL-29（补充） Approval Labeling STANDARD
2022/12/19 SUPPL-27（补充） Approval Labeling STANDARD
2022/12/19 SUPPL-23（补充） Approval Labeling STANDARD
2022/12/19 SUPPL-22（补充） Approval Labeling STANDARD
2022/12/19 SUPPL-19（补充） Approval Labeling STANDARD
2022/12/19 SUPPL-18（补充） Approval Labeling STANDARD
2022/12/19 SUPPL-15（补充） Approval Labeling STANDARD
2022/12/19 SUPPL-14（补充） Approval Labeling STANDARD
2022/12/19 SUPPL-13（补充） Approval Labeling STANDARD
2015/09/29 SUPPL-12（补充） Approval Labeling STANDARD
2015/09/29 SUPPL-11（补充） Approval Labeling STANDARD
2013/04/22 SUPPL-10（补充） Approval Labeling STANDARD
2012/07/25 SUPPL-9（补充） Approval Labeling STANDARD
2012/03/29 SUPPL-8（补充） Approval Labeling
2011/11/28 SUPPL-7（补充） Approval Labeling
2011/05/16 SUPPL-6（补充） Approval Labeling
2010/03/09 SUPPL-2（补充） Approval Labeling
2004/09/10 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: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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