Manages moderately severe acute pain. ANDA 217166, held by Aspiro. Ketorolac Tromethamine.
As of Nov 15, 2026, ANDA 217166 (Ketorolac Tromethamine), held by Aspiro, was first approved by FDA on Jun 20, 2023, with 1 approved supplement 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 |
|---|---|---|---|
| Jun 20, 2023 | Original application | Approved | None posted |
| Ketorolac Tromethamine15MG/ML · injectable;injection | Ketorolac Tromethamine | Rx |
| Ketorolac Tromethamine30MG/ML · injectable;injection | Ketorolac Tromethamine | Rx |
| Nov 21, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 20, 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
