Treats inflammation and pain associated with ocular surgery. ANDA 214894, held by Dr Reddys. Difluprednate.
As of Nov 15, 2026, ANDA 214894 (Difluprednate), held by Dr Reddys, was first approved by FDA on Nov 16, 2022, with 0 approved supplements and 0 published complete response letters.
Difluprednate ophthalmic emulsion (0.05%) 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%) is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion (0.05%) is indicated for the treatment of endogenous anterior uveitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 16, 2022 | 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
