美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=NIPRIDE RTU IN SODIUM CHLORIDE 0.9%"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% 209387 001 NDA SODIUM NITROPRUSSIDE SOLUTION;INTRAVENOUS 50MG/100ML (0.5MG/ML) Yes Yes 2017/03/08 2017/03/08 EXELA PHARMA Prescription
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% 209387 002 NDA SODIUM NITROPRUSSIDE SOLUTION;INTRAVENOUS 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2017/03/08 2017/12/07 EXELA PHARMA Discontinued
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% 209387 003 NDA SODIUM NITROPRUSSIDE SOLUTION;INTRAVENOUS 20MG/100ML (0.2MG/ML) Yes Yes 2017/03/08 2018/07/13 EXELA PHARMA Prescription
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