NDA 22428, held by Harrow Eye. Moxifloxacin Hydrochloride.
As of Nov 14, 2026, NDA 22428 (Moxeza), held by Harrow Eye, was first approved by FDA on Nov 19, 2010, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 19, 2010 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| MoxezaEQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution/drops;ophthalmic | Moxifloxacin Hydrochloride | DiscontinuedReference drug |
| Aug 11, 2021 | Supplement 10Labeling · Standard review | Approved | |
| Feb 17, 2017 | Supplement 9Labeling · Standard review | Approved | |
| Sep 14, 2012 | Supplement 2Labeling · Standard review | Approved | |
| Oct 18, 2011 | Supplement 1Labeling · Standard review | Approved | |
| Nov 19, 2010 | Original applicationNew dosage form · 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
