ANDA 201941, held by Chartwell Rx. Bromfenac Sodium.
As of Nov 15, 2026, ANDA 201941 (Bromfenac Sodium), held by Chartwell Rx, was first approved by FDA on Feb 10, 2015, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 10, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bromfenac SodiumEQ 0.09% ACID ยท solution/drops;ophthalmic | Bromfenac Sodium | Discontinued |
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
