NDA 22427, held by Abbvie. Ketorolac Tromethamine.
As of Nov 14, 2026, NDA 22427 (Acuvail), held by Abbvie, was first approved by FDA on Jul 22, 2009, with 5 approved supplements and 0 published complete response letters.
ACUVAIL is indicated for the treatment of pain and inflammation following cataract surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 22, 2009 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acuvail0.45% · solution/drops;ophthalmic | Ketorolac Tromethamine | RxReference drug |
| May 24, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Dec 4, 2014 | Supplement 5Labeling · Standard review | Approved | |
| Nov 16, 2012 | Supplement 4Manufacturing | Approved | |
| Nov 15, 2012 | Supplement 3Labeling · Standard review | Approved | |
| Jun 28, 2010 | Supplement 1Labeling | Approved | |
| Jul 22, 2009 | 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
