药品注册申请号：211968
申请类型：ANDA (仿制药申请)
申请人：NEPHRON
申请人全名：NEPHRON PHARMACEUTICALS CORPORATION
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 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;INJECTION 450MG/50ML (9MG/ML) No No AP 2020/04/23 2020/04/23 Prescription
002 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;INJECTION 900MG/100ML No No AP 2020/04/23 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
2020/04/23 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
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:SODIUM CHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:450MG/50ML (9MG/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
016677 003 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;INJECTION 450MG/50ML (9MG/ML) Prescription Yes Yes AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018803 003 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;INJECTION 450MG/50ML (9MG/ML) Prescription Yes Yes AP 1982/10/29 HOSPIRA
019465 002 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;INJECTION 450MG/50ML (9MG/ML) Prescription Yes No AP 1985/07/15 HOSPIRA
020178 002 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;INJECTION 450MG/50ML (9MG/ML) Prescription Yes No AP 1992/12/07 BAXTER HLTHCARE
211968 001 ANDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;INJECTION 450MG/50ML (9MG/ML) Prescription No No AP 2020/04/23 NEPHRON
活性成分:SODIUM CHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:900MG/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
016677 001 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;INJECTION 900MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
019465 001 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;INJECTION 900MG/100ML Prescription Yes Yes AP 1985/07/15 HOSPIRA
020178 001 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;INJECTION 900MG/100ML Prescription Yes Yes AP 1992/12/07 BAXTER HLTHCARE
211968 002 ANDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;INJECTION 900MG/100ML Prescription No No AP 2020/04/23 NEPHRON
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2024 DrugFuture->U.S. FDA Drugs Database