Treats postoperative inflammation and reduction of ocular pain. ANDA 203395, held by Sentiss. Bromfenac Sodium.
As of Nov 15, 2026, ANDA 203395 (Bromfenac Sodium), held by Sentiss, was first approved by FDA on Jan 22, 2014, 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 |
|---|---|---|---|
| Jan 22, 2014 | 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
