Treats pain and inflammation associated with cataract surgery. NDA 203491, held by Harrow Eye. Nepafenac.
As of Nov 14, 2026, NDA 203491 (Ilevro), held by Harrow Eye, was first approved by FDA on Oct 16, 2012, with 7 approved supplements and 0 published complete response letters.
ILEVRO 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 2012 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ilevro0.3% · suspension/drops;ophthalmic | Nepafenac | RxReference drug |
| Nov 10, 2015 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Sep 28, 2015 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 3, 2014 | Supplement 6Manufacturing · Standard review | Approved | |
| Feb 13, 2014 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 5, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 9, 2013 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Dec 14, 2012 | Supplement 1Labeling · Standard review | Approved | |
| Oct 16, 2012 | Original applicationNew formulation or manufacturer · 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
