Orange Book product
STATROL EQ 3.5MG BASE/ML;16,250 UNITS/ML
Orange Book ANDA 062339 · ALCON LABORATORIES INC · Discontinued
Key facts
| Proprietary name | STATROL |
|---|---|
| Active ingredients | NEOMYCIN SULFATE, POLYMYXIN B SULFATE |
| Strength | EQ 3.5MG BASE/ML;16,250 UNITS/ML |
| Dosage form | SOLUTION/DROPS |
| Route | OPHTHALMIC |
| Application | ANDA062339 |
| Applicant holder | ALCON LABORATORIES INC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Nov 30, 1984 |
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.