Treats inflammation and pain associated with ocular surgery. ANDA 219441, held by Caplin. Difluprednate.
As of Nov 15, 2026, ANDA 219441 (Difluprednate), held by Caplin, was first approved by FDA on Dec 13, 2024, with 0 approved supplements and 0 published complete response letters.
Difluprednate ophthalmic emulsion is a topical corticosteroid that is 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 also indicated for the treatment of endogenous anterior uveitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 13, 2024 | 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
