ANDA 74790, held by Chartwell Rx. Ketorolac Tromethamine.
As of Nov 15, 2026, ANDA 74790 (Ketorolac Tromethamine), held by Chartwell Rx, was first approved by FDA on Jun 26, 1997, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 26, 1997 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ketorolac Tromethamine10MG ยท tablet;oral | 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
