NDA 216227, held by Harrow Eye. Chloroprocaine Hydrochloride.
As of Nov 13, 2026, NDA 216227 (Iheezo), held by Harrow Eye, was first approved by FDA on Sep 27, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2022 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Iheezo3% · gel;ophthalmic | Chloroprocaine Hydrochloride | RxReference drug |
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