药品注册申请号:065048
申请类型:ANDA (仿制药申请)
申请人:HIKMA
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 CEFUROXIME SODIUM CEFUROXIME SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 750MG BASE/VIAL No Yes AB 2004/01/09 2004/01/09 Prescription
002 CEFUROXIME SODIUM CEFUROXIME SODIUM INJECTABLE;INJECTION EQ 1.5GM BASE/VIAL No Yes AP 2004/01/09 Prescription
003 CEFUROXIME CEFUROXIME Injectable; Injection 1.5G/20ML No No None -- Prescription
004 CEFUROXIME CEFUROXIME Injectable; Injection 1.5G/100ML No No None -- 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
2021/07/07 SUPPL-19(补充) Approval Labeling STANDARD
2021/07/07 SUPPL-18(补充) Approval Labeling STANDARD
2019/11/16 SUPPL-17(补充) Approval Labeling STANDARD
2016/04/12 SUPPL-14(补充) Approval Labeling STANDARD
2008/01/16 SUPPL-8(补充) Approval Labeling
2004/01/09 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
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:CEFUROXIME SODIUM 剂型/给药途径:INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 规格:EQ 750MG BASE/VIAL 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
050558 002 NDA ZINACEF CEFUROXIME SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 750MG BASE/VIAL Discontinued Yes No AB 1983/10/19 PAI HOLDINGS PHARM
064125 001 ANDA CEFUROXIME SODIUM CEFUROXIME SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 750MG BASE/VIAL Prescription No No AB 1997/05/30 ACS DOBFAR SPA
065048 001 ANDA CEFUROXIME SODIUM CEFUROXIME SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 750MG BASE/VIAL Prescription No Yes AB 2004/01/09 HIKMA
活性成分:CEFUROXIME SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1.5GM BASE/VIAL 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
050558 003 NDA ZINACEF CEFUROXIME SODIUM INJECTABLE;INJECTION EQ 1.5GM BASE/VIAL Discontinued Yes No AP 1983/10/19 PAI HOLDINGS PHARM
064125 002 ANDA CEFUROXIME SODIUM CEFUROXIME SODIUM INJECTABLE;INJECTION EQ 1.5GM BASE/VIAL Prescription No No AP 1997/05/30 ACS DOBFAR SPA
050780 002 NDA CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER CEFUROXIME SODIUM INJECTABLE;INJECTION EQ 1.5GM BASE/VIAL Discontinued Yes No AP 2001/02/21 B BRAUN
065048 002 ANDA CEFUROXIME SODIUM CEFUROXIME SODIUM INJECTABLE;INJECTION EQ 1.5GM BASE/VIAL Prescription No Yes AP 2004/01/09 HIKMA
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