Treats postoperative inflammation and reduction of ocular pain. ANDA 214340, held by Alembic. Bromfenac Sodium.
As of Nov 15, 2026, ANDA 214340 (Bromfenac Sodium), held by Alembic, was first approved by FDA on Jul 8, 2024, with 0 approved supplements and 0 published complete response letters.
Bromfenac ophthalmic solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. BROMFENAC is a nonsteroidal anti-inflammatory drug (NSAID)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 8, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bromfenac SodiumEQ 0.07% 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
