Treats inflammation and pain associated with ocular surgery. ANDA 213774, held by Alembic. Difluprednate.
As of Nov 15, 2026, ANDA 213774 (Difluprednate), held by Alembic, was first approved by FDA on Jan 26, 2026, 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 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 |
|---|---|---|---|
| Jan 26, 2026 | 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
