Manages moderately severe acute pain. ANDA 215745, held by Leading. Ketorolac Tromethamine.
As of Nov 15, 2026, ANDA 215745 (Ketorolac Tromethamine), held by Leading, was first approved by FDA on Feb 23, 2023, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac tromethamine tablets are indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ketorolac Tromethamine10MG · tablet;oral | Ketorolac Tromethamine | Rx |
| Nov 21, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 23, 2023 | Original application | Approved | None posted |
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
