ANDA 203368, held by Rising. Bromfenac Sodium.
As of Nov 15, 2026, ANDA 203368 (Bromfenac Sodium), held by Rising, was first approved by FDA on Jun 3, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 3, 2019 | 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
