Orange Book product
AZELASTINE HYDROCHLORIDE 0.05%
Orange Book ANDA 207411 · SOMERSET THERAPEUTICS LLC · Prescription
Key facts
| Proprietary name | AZELASTINE HYDROCHLORIDE |
|---|---|
| Active ingredients | AZELASTINE HYDROCHLORIDE |
| Strength | 0.05% |
| Dosage form | SOLUTION/DROPS |
| Route | OPHTHALMIC |
| Application | ANDA207411 |
| Applicant holder | SOMERSET THERAPEUTICS LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AT |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Mar 29, 2019 |
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.