Orange Book product
POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL
Orange Book ANDA 202766 · XELLIA PHARMACEUTICALS APS · Prescription
Key facts
| Proprietary name | POLYMYXIN B SULFATE |
|---|---|
| Active ingredients | POLYMYXIN B SULFATE |
| Strength | EQ 500,000 UNITS BASE/VIAL |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA202766 |
| Applicant holder | XELLIA PHARMACEUTICALS APS |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Jan 15, 2014 |
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.