NDA 21114, held by Alcon Pharms Ltd. Levobetaxolol Hydrochloride.
As of Nov 14, 2026, NDA 21114 (Betaxon), held by Alcon Pharms Ltd, was first approved by FDA on Feb 23, 2000, with 3 approved supplements and 0 published complete response letters.
| Sep 28, 2006 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Feb 23, 2000 | Original applicationNew active ingredient · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| BetaxonEQ 0.5% BASE · suspension/drops;ophthalmic | Levobetaxolol Hydrochloride | Discontinued |
| Mar 9, 2010 | Supplement 3Labeling · Standard review | Approved | |
| Sep 28, 2006 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Jun 11, 2006 | Supplement 11Labeling · Priority review | Approved | None posted |
| Feb 23, 2000 | Original applicationNew active ingredient · 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
