Treats inflammation and pain associated with ocular surgery. ANDA 218191, held by Upsher Smith Labs. Difluprednate.
As of Nov 15, 2026, ANDA 218191 (Difluprednate), held by Upsher Smith Labs, was first approved by FDA on Feb 11, 2025, with 0 approved supplements and 0 published complete response letters.
Difluprednate ophthalmic emulsion is a corticosteroid indicated for: The treatment of inflammation and pain associated with ocular surgery The treatment of endogenous anterior uveitis 1.1 Ocular Surgery Difluprednate ophthalmic emulsion 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is indicated for the treatment of endogenous anterior uveitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 11, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Difluprednate0.05% · emulsion;ophthalmic | Difluprednate | 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
