ANDA 76722, held by Gland Pharma Ltd. Ketorolac Tromethamine.
As of Nov 15, 2026, ANDA 76722 (Ketorolac Tromethamine), held by Gland Pharma Ltd, was first approved by FDA on Jul 27, 2004, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 27, 2004 | Original application | Approved |
| Ketorolac Tromethamine15MG/ML · injectable;injection | Ketorolac Tromethamine | Discontinued |
| Ketorolac Tromethamine30MG/ML · injectable;injection | Ketorolac Tromethamine | Discontinued |
| Ketorolac Tromethamine60MG/2ML · injectable; injection | Ketorolac Tromethamine | Rx |
| May 9, 2016 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jul 27, 2004 | Original application | Approved |
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
