Orange Book product
EPINASTINE HYDROCHLORIDE 0.05%
Orange Book ANDA 090951 · SOMERSET THERAPEUTICS LLC · Prescription
Key facts
| Proprietary name | EPINASTINE HYDROCHLORIDE |
|---|---|
| Active ingredients | EPINASTINE HYDROCHLORIDE |
| Strength | 0.05% |
| Dosage form | SOLUTION/DROPS |
| Route | OPHTHALMIC |
| Application | ANDA090951 |
| Applicant holder | SOMERSET THERAPEUTICS LLC |
| Marketing status | Prescription |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Oct 31, 2011 |
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.