Orange Book product
OTOBIOTIC 5MG/ML;EQ 10,000 UNITS BASE/ML
Orange Book ANDA 062302 · SCHERING CORP SUB SCHERING PLOUGH CORP · Discontinued
Key facts
| Proprietary name | OTOBIOTIC |
|---|---|
| Active ingredients | HYDROCORTISONE, POLYMYXIN B SULFATE |
| Strength | 5MG/ML;EQ 10,000 UNITS BASE/ML |
| Dosage form | SOLUTION/DROPS |
| Route | OTIC |
| Application | ANDA062302 |
| Applicant holder | SCHERING CORP SUB SCHERING PLOUGH CORP |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jan 1, 1982 |
At a glance
- None 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.