Treats postoperative inflammation and prevention of ocular pain. ANDA 211239, held by Lupin. Bromfenac Sodium.
As of Nov 15, 2026, ANDA 211239 (Bromfenac Sodium), held by Lupin, was first approved by FDA on Feb 2, 2024, with 0 approved supplements and 0 published complete response letters.
Bromfenac ophthalmic solution, 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 2, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bromfenac SodiumEQ 0.075% 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
