Treats postoperative inflammation and prevention of ocular pain. NDA 206911, held by Sun Pharm. Bromfenac Sodium.
As of Nov 13, 2026, NDA 206911 (Bromsite), held by Sun Pharm, was first approved by FDA on Apr 8, 2016, with 1 approved supplement and 0 published complete response letters.
BromSite (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 |
|---|---|---|---|
| Apr 8, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| BromsiteEQ 0.075% ACID · solution/drops;ophthalmic | Bromfenac Sodium | RxReference drug |
| Mar 9, 2023 | Supplement 8Labeling · Standard review | Approved | |
| Apr 8, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
