Drug application
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE)
Drugs@FDA ANDA 220938 · ORBICULAR PHARM TECH
Key facts
| Drug name | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE |
|---|---|
| Active ingredients | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE |
| Application type | ANDA |
| Application number | 220938 |
| Company | ORBICULAR PHARM TECH |
| Dosage forms | SOLUTION/DROPS, OTIC |
| Strength | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML |
| Marketing status | Prescription |
| TE codes | AT |
| Reference listed drug | No |
| Latest submission status date | Aug 27, 2026 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 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.