Treats postoperative inflammation and reduction of ocular pain. ANDA 210962, held by Amneal. Bromfenac Sodium.
As of Nov 15, 2026, ANDA 210962 (Bromfenac Sodium), held by Amneal, was first approved by FDA on Jul 29, 2024, with 0 approved supplements and 0 published complete response letters.
Bromfenac ophthalmic solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bromfenac SodiumEQ 0.07% ACID · solution/drops;ophthalmic | Bromfenac Sodium | Rx |
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
