Relieves ocular itching due to seasonal allergic conjunctivitis. ANDA 78434, held by Chartwell Rx. Ketorolac Tromethamine.
As of Nov 15, 2026, ANDA 78434 (Ketorolac Tromethamine), held by Chartwell Rx, was first approved by FDA on Nov 5, 2009, with 1 approved supplement and 0 published complete response letters.
Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. Ketorolac tromethamine ophthalmic solution is a nonsteroidal, anti-inflammatory indicated for: The treatment of inflammation following cataract surgery. The temporary relief of ocular itching due to seasonal allergic conjunctivitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 5, 2009 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ketorolac Tromethamine0.5% · solution/drops;ophthalmic | Ketorolac Tromethamine | Discontinued |
| Oct 15, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 5, 2009 | 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
