| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 017512 | 006 | NDA | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | Yes | No | 1978/09/27 | Approved Prior to Jan 1, 1982 | BAXTER HLTHCARE | Prescription |
| DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 020163 | 003 | NDA | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | Yes | No | 1992/12/04 | 1992/12/04 | BAXTER HLTHCARE | Prescription |