Orange Book product
OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML
Orange Book NDA 013684 · BAXTER HEALTHCARE CORP · Prescription
Key facts
| Proprietary name | OSMITROL 20% IN WATER IN PLASTIC CONTAINER |
|---|---|
| Active ingredients | MANNITOL |
| Strength | 20GM/100ML |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | NDA013684 |
| Applicant holder | BAXTER HEALTHCARE CORP |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Jan 1, 1982 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes 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.