Manages moderately severe acute pain. ANDA 201155, held by Onesource Specialty. Ketorolac Tromethamine.
As of Nov 15, 2026, ANDA 201155 (Ketorolac Tromethamine), held by Onesource Specialty, was first approved by FDA on Aug 4, 2014, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Acute Pain in Adult Patients Ketorolac tromethamine is 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. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 4, 2014 | Original application | Approved | None posted |
| Ketorolac Tromethamine15MG/ML · injectable;injection | Ketorolac Tromethamine | Discontinued |
| Ketorolac Tromethamine30MG/ML · injectable;injection | Ketorolac Tromethamine | Discontinued |
| Nov 21, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 10, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 10, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 28, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 9, 2016 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 4, 2014 | 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
