ANDA 75284, held by Pliva. Ketorolac Tromethamine.
As of Nov 15, 2026, ANDA 75284 (Ketorolac Tromethamine), held by Pliva, was first approved by FDA on Jun 23, 1999, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 1999 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ketorolac Tromethamine10MG · tablet;oral | Ketorolac Tromethamine | Discontinued |
| May 9, 2016 | Supplement 11Labeling · Standard review | Approved | None posted |
| Feb 6, 2007 | Supplement 6Labeling | Approved | None posted |
| Apr 12, 2005 | Supplement 5Labeling | Approved | None posted |
| Jul 7, 2000 | Supplement 1Manufacturing | Approved | None posted |
| Jun 23, 1999 | 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
