Orange Book product
OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE
Orange Book ANDA 078350 · APOTEX INC · Over the counter
Key facts
| Proprietary name | OLOPATADINE HYDROCHLORIDE |
|---|---|
| Active ingredients | OLOPATADINE HYDROCHLORIDE |
| Strength | EQ 0.1% BASE |
| Dosage form | SOLUTION/DROPS |
| Route | OPHTHALMIC |
| Application | ANDA078350 |
| Applicant holder | APOTEX INC |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Dec 7, 2015 |
At a glance
- 10–99 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.