Manages moderately severe acute pain. ANDA 217038, held by Zydus Lifesciences. Ketorolac Tromethamine.
As of Nov 15, 2026, ANDA 217038 (Ketorolac Tromethamine), held by Zydus Lifesciences, was first approved by FDA on Oct 21, 2022, 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 |
|---|---|---|---|
| Oct 21, 2022 | 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 |
| Oct 21, 2022 | 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
