NDA 208135, held by Alcon Labs. Tetracaine Hydrochloride.
As of Nov 13, 2026, NDA 208135 (Tetracaine Hydrochloride), held by Alcon Labs, was first approved by FDA on Feb 29, 2016, with 1 approved supplement and 0 published complete response letters.
Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 29, 2016 | Original applicationTYPE 7 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tetracaine Hydrochloride0.5% · solution;ophthalmic | Tetracaine Hydrochloride | RxReference drug |
| Feb 28, 2022 | Supplement 5Labeling · Standard review | Approved | |
| Feb 29, 2016 | Original applicationTYPE 7 · Standard 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
