Orange Book product
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Orange Book ANDA 220938 · ORBICULAR PHARMACEUTICAL TECHNOLOGIES PVT LTD · Prescription
Key facts
| Proprietary name | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE |
|---|---|
| Active ingredients | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE |
| Strength | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML |
| Dosage form | SOLUTION/DROPS |
| Route | OTIC |
| Application | ANDA220938 |
| Applicant holder | ORBICULAR PHARMACEUTICAL TECHNOLOGIES PVT LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AT |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Aug 27, 2026 |
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.