Treats itching of the eye associated with allergic conjunctivitis. ANDA 78738, held by Sun Pharm. Azelastine Hydrochloride.
As of Nov 15, 2026, ANDA 78738 (Azelastine Hydrochloride), held by Sun Pharm, was first approved by FDA on Jun 21, 2010, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Azelastine hydrochloride ophthalmic solution is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 21, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Azelastine Hydrochloride0.05% · solution/drops;ophthalmic | Azelastine Hydrochloride | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
