药品注册申请号：091375
申请类型：ANDA (仿制药申请)
申请人：HIKMA FARMACEUTICA
申请人全名：HIKMA FARMACEUTICA (PORTUGAL) SA
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 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 250MG/50ML (EQ 5MG/ML) No No AP 2011/09/16 2011/09/16 Prescription
002 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 500MG/100ML (EQ 5MG/ML) No No AP 2011/09/16 Prescription
003 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 750MG/150ML (EQ 5MG/ML) No No AP 2011/09/16 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
2024/09/20 SUPPL-23（补充） Approval Labeling STANDARD
2019/05/03 SUPPL-15（补充） Approval Labeling STANDARD
2019/04/15 SUPPL-12（补充） Approval Labeling STANDARD
2019/04/15 SUPPL-9（补充） Approval Labeling STANDARD
2018/10/18 SUPPL-14（补充） Approval Labeling STANDARD
2016/01/04 SUPPL-5（补充） Approval Labeling STANDARD
2013/11/05 SUPPL-4（补充） Approval Labeling STANDARD
2012/07/25 SUPPL-2（补充） Approval REMS
2012/02/10 SUPPL-1（补充） Approval Labeling
2011/09/16 ORIG-1（原始申请） Approval Not Applicable
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:LEVOFLOXACIN 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 250MG/50ML (EQ 5MG/ML) 治疗等效代码:AP
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
090343 001 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 250MG/50ML (EQ 5MG/ML) Prescription No Yes AP 2011/07/07 INFORLIFE
091375 001 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 250MG/50ML (EQ 5MG/ML) Prescription No No AP 2011/09/16 HIKMA FARMACEUTICA
200674 001 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 250MG/50ML (EQ 5MG/ML) Prescription No No AP 2013/06/19 FRESENIUS KABI USA
091397 001 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 250MG/50ML (EQ 5MG/ML) Prescription No No AP 2013/08/08 BAXTER HLTHCARE CORP
078579 001 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 250MG/50ML (EQ 5MG/ML) Prescription No No AP 2015/09/03 HOSPIRA
206919 001 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 250MG/50ML (EQ 5MG/ML) Discontinued No No AP 2016/02/10 EUGIA PHARMA
206908 001 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 250MG/50ML (EQ 5MG/ML) Prescription No No AP 2020/12/30 GLAND PHARMA LTD
216164 001 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 250MG/50ML (EQ 5MG/ML) Discontinued No No AP 2024/01/29 KNACK
活性成分:LEVOFLOXACIN 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 500MG/100ML (EQ 5MG/ML) 治疗等效代码:AP
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
090343 002 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 500MG/100ML (EQ 5MG/ML) Prescription No Yes AP 2011/07/07 INFORLIFE
091375 002 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 500MG/100ML (EQ 5MG/ML) Prescription No No AP 2011/09/16 HIKMA FARMACEUTICA
200674 002 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 500MG/100ML (EQ 5MG/ML) Prescription No No AP 2013/06/19 FRESENIUS KABI USA
091397 002 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 500MG/100ML (EQ 5MG/ML) Prescription No No AP 2013/08/08 BAXTER HLTHCARE CORP
078579 002 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 500MG/100ML (EQ 5MG/ML) Prescription No No AP 2015/09/03 HOSPIRA
206919 002 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 500MG/100ML (EQ 5MG/ML) Discontinued No No AP 2016/02/10 EUGIA PHARMA
206908 002 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 500MG/100ML (EQ 5MG/ML) Prescription No No AP 2020/12/30 GLAND PHARMA LTD
216164 002 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 500MG/100ML (EQ 5MG/ML) Discontinued No No AP 2024/01/29 KNACK
活性成分:LEVOFLOXACIN 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 750MG/150ML (EQ 5MG/ML) 治疗等效代码:AP
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
090343 003 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 750MG/150ML (EQ 5MG/ML) Prescription No Yes AP 2011/07/07 INFORLIFE
091375 003 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 750MG/150ML (EQ 5MG/ML) Prescription No No AP 2011/09/16 HIKMA FARMACEUTICA
200674 003 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 750MG/150ML (EQ 5MG/ML) Prescription No No AP 2013/06/19 FRESENIUS KABI USA
091397 003 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 750MG/150ML (EQ 5MG/ML) Prescription No No AP 2013/08/08 BAXTER HLTHCARE CORP
078579 003 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 750MG/150ML (EQ 5MG/ML) Prescription No No AP 2015/09/03 HOSPIRA
206919 003 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 750MG/150ML (EQ 5MG/ML) Discontinued No No AP 2016/02/10 EUGIA PHARMA
206908 003 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 750MG/150ML (EQ 5MG/ML) Prescription No No AP 2020/12/30 GLAND PHARMA LTD
216164 003 ANDA LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN INJECTABLE;INJECTION EQ 750MG/150ML (EQ 5MG/ML) Discontinued No No AP 2024/01/29 KNACK
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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