NDA 20811, held by Allergan. Ketorolac Tromethamine.
As of Nov 15, 2026, NDA 20811 (Acular Preservative Free), held by Allergan, was first approved by FDA on Nov 3, 1997, with 2 approved supplements and 0 published complete response letters.
| Feb 8, 2002 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Nov 3, 1997 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acular Preservative Free0.5% · solution/drops;ophthalmic | Ketorolac Tromethamine | Discontinued |
| Feb 8, 2002 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jul 7, 2000 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 3, 1997 | 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
