ANDA 203376, held by Epic Pharma LLC. Ketorolac Tromethamine.
As of Nov 15, 2026, ANDA 203376 (Ketorolac Tromethamine), held by Epic Pharma LLC, was first approved by FDA on Feb 10, 2014, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 10, 2014 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ketorolac Tromethamine0.45% · solution/drops;ophthalmic | Ketorolac Tromethamine | Discontinued |
| Oct 18, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 10, 2014 | Original application | 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
