Orange Book product
MANNITOL 20% IN PLASTIC CONTAINER 20GM/100ML
Orange Book NDA 019603 · OTSUKA ICU MEDICAL LLC · Prescription
Key facts
| Proprietary name | MANNITOL 20% IN PLASTIC CONTAINER |
|---|---|
| Active ingredients | MANNITOL |
| Strength | 20GM/100ML |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | NDA019603 |
| Applicant holder | OTSUKA ICU MEDICAL LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jan 8, 1990 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.