药品注册申请号:208122
申请类型:ANDA (仿制药申请)
申请人:FRESENIUS KABI USA
申请人全名:FRESENIUS KABI USA 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 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 450MG/100ML No No AP 2018/07/23 2018/07/23 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
2022/06/10 SUPPL-11(补充) Approval Manufacturing (CMC) UNKNOWN
2020/11/30 SUPPL-6(补充) Approval Manufacturing (CMC) UNKNOWN
2020/11/05 SUPPL-2(补充) Approval Labeling STANDARD
2018/07/23 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:SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:450MG/100ML 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
018016 001 NDA SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 450MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018090 001 NDA SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 450MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 ICU MEDICAL INC
019635 001 NDA SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 450MG/100ML Prescription Yes No AP 1988/03/09 B BRAUN
019759 001 NDA SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 450MG/100ML Prescription No No AP 1988/06/08 HOSPIRA
208122 001 ANDA SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 450MG/100ML Prescription No No AP 2018/07/23 FRESENIUS KABI USA
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药品NDC数据与药品包装、标签说明书
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