Treats ocular itching associated with allergic conjunctivitis. NDA 208694, held by Harrow Eye. Cetirizine Hydrochloride.
As of Nov 14, 2026, NDA 208694 (Zerviate), held by Harrow Eye, was first approved by FDA on May 30, 2017, with 1 approved supplement and 0 published complete response letters.
ZERVIATE (cetirizine ophthalmic solution) 0.24% is indicated for the treatment of ocular itching associated with allergic conjunctivitis. ZERVIATE (cetirizine ophthalmic solution) 0.24% is a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated with allergic conjunctivitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 30, 2017 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ZerviateEQ 0.24% BASE · solution/drops;ophthalmic | Cetirizine Hydrochloride | RxReference drug |
| Feb 5, 2020 | Supplement 6Labeling · Standard review | Approved | |
| May 30, 2017 | Original applicationNew dosage form · Priority review | Approved |
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
