Treats postoperative inflammation and reduction of ocular pain. ANDA 204813, held by Eugia Pharma. Bromfenac Sodium.
As of Nov 15, 2026, ANDA 204813 (Bromfenac Sodium), held by Eugia Pharma, was first approved by FDA on Mar 18, 2022, with 0 approved supplements and 0 published complete response letters.
Bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 18, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bromfenac SodiumEQ 0.09% 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
