NDA 21493, held by Allergan. Gatifloxacin.
As of Nov 14, 2026, NDA 21493 (Zymar), held by Allergan, was first approved by FDA on Mar 28, 2003, with 6 approved supplements and 0 published complete response letters.
| Mar 21, 2017 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Mar 28, 2003 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zymar0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution/drops;ophthalmic | Gatifloxacin | DiscontinuedReference drug |
| Mar 21, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Mar 21, 2017 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| May 21, 2015 | Supplement 10Labeling · Standard review | Approved | |
| Jun 20, 2005 | Supplement 7Labeling · Standard review | Approved | |
| Jun 20, 2005 | Supplement 6Manufacturing · Standard review | Approved | |
| Jul 23, 2004 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 28, 2003 | 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
