Drug application
SORBITOL-MANNITOL IN PLASTIC CONTAINER (MANNITOL, SORBITOL)
Drugs@FDA NDA 018316 · OTSUKA ICU MEDCL
Key facts
| Drug name | SORBITOL-MANNITOL IN PLASTIC CONTAINER |
|---|---|
| Active ingredients | MANNITOL, SORBITOL |
| Application type | NDA |
| Application number | 018316 |
| Company | OTSUKA ICU MEDCL |
| Dosage forms | SOLUTION, IRRIGATION |
| Strength | 540MG/100ML;2.7GM/100ML |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | Feb 22, 1980 |
At a glance
- 1–9 Submissions
- 10–99 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.