Manages moderately severe acute pain. ANDA 215788, held by Pharmazone. Ketorolac Tromethamine.
As of Nov 15, 2026, ANDA 215788 (Ketorolac Tromethamine), held by Pharmazone, was first approved by FDA on Mar 23, 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 USP and other treatment options before deciding to use Ketorolac Tromethamine Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac Tromethamine Tablets USP 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 |
|---|---|---|---|
| Mar 23, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ketorolac Tromethamine10MG · tablet;oral | Ketorolac Tromethamine | Rx |
| Nov 21, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 23, 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
