FdaApplication
NDA 018365
Identifiers
- fda_app_no: NDA018365
Properties
| Property | Value |
|---|---|
| applicant_name | OTSUKA ICU MEDICAL LLC |
| application_type | NDA |
| approval_date | 1983-07-05 |
Products (9)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;74.5MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;149MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE;INJECTION |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;298MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;298MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;149MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;74.5MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
9 products