ANDA 75222, held by Hikma. Ketorolac Tromethamine.
As of Nov 15, 2026, ANDA 75222 (Ketorolac Tromethamine), held by Hikma, was first approved by FDA on Apr 26, 1999, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 1999 | Original application | Approved | None posted |
| Ketorolac Tromethamine15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ketorolac Tromethamine | Discontinued |
| Ketorolac Tromethamine30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ketorolac Tromethamine | Discontinued |
| Nov 21, 2024 | Supplement 23Labeling · Standard review | Approved | None posted |
| Jul 11, 2024 | Supplement 22Labeling · Standard review | Approved | None posted |
| Nov 9, 2022 | Supplement 21Labeling · Standard review | Approved | None posted |
| Apr 28, 2021 | Supplement 20Labeling · Standard review | Approved | None posted |
| Mar 8, 2011 | Supplement 14Labeling | Approved | None posted |
| Aug 5, 2008 | Supplement 13Labeling | Approved | None posted |
| Jul 21, 2007 | Supplement 12Labeling | Approved | None posted |
| Feb 7, 2007 | Supplement 11Labeling | Approved | None posted |
| Dec 20, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Sep 17, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Apr 3, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Apr 26, 1999 | 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
