FdaApplication
NDA 019437
Identifiers
- fda_app_no: NDA019437
Properties
| Property | Value |
|---|---|
| applicant_name | ICU MEDICAL INC |
| application_type | NDA |
| approval_date | 1986-04-03 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AMINOSYN II 10% W/ ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML | INJECTABLE;INJECTION |
| AMINOSYN II 3.5% M | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | 3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML | INJECTABLE;INJECTION |
| AMINOSYN II 7% W/ ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML | INJECTABLE;INJECTION |
| AMINOSYN II 8.5% W/ ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML | INJECTABLE;INJECTION |
| AMINOSYN II 8.5% W/ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC | 8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100ML | INJECTABLE;INJECTION |
5 products