Treats postoperative inflammation and reduction of ocular pain. ANDA 202903, held by Lupin. Bromfenac Sodium.
As of Nov 15, 2026, ANDA 202903 (Bromfenac Sodium), held by Lupin, was first approved by FDA on Aug 15, 2023, with 0 approved supplements and 0 published complete response letters.
Bromfenac ophthalmic solution, 0.09% is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 15, 2023 | 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
