Drug application
ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER (DEXTROSE, POTASSIUM CHLORIDE, POTASSIUM PHOSPHATE, DIBASIC and 2 more)
Drugs@FDA NDA 019870 · B BRAUN
Key facts
| Drug name | ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER |
|---|---|
| Active ingredients | DEXTROSE, POTASSIUM CHLORIDE, POTASSIUM PHOSPHATE, DIBASIC, SODIUM ACETATE, SODIUM CHLORIDE |
| Application type | NDA |
| Application number | 019870 |
| Company | B BRAUN |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | 5GM/100ML;150MG/100ML;130MG/100ML;280MG/100ML;91MG/100ML |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | Jun 10, 1993 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.