ANDA 75348, held by Apothecon. Ketorolac Tromethamine.
As of Nov 15, 2026, ANDA 75348 (Ketorolac Tromethamine), held by Apothecon, was first approved by FDA on Nov 29, 2000, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 29, 2000 | Original application | Approved |
| Ketorolac Tromethamine15MG/ML · injectable;injection | Ketorolac Tromethamine | Discontinued |
| Ketorolac Tromethamine30MG/ML · injectable;injection | Ketorolac Tromethamine | Discontinued |
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
