Treats postoperative inflammation and reduction of ocular pain. ANDA 211029, held by Gland. Bromfenac Sodium.
As of Nov 15, 2026, ANDA 211029 (Bromfenac Sodium), held by Gland, was first approved by FDA on Mar 17, 2020, 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 17, 2020 | 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
