NDA 208219, held by Bausch And Lomb Inc. Loteprednol Etabonate.
As of Nov 13, 2026, NDA 208219 (Lotemax Sm), held by Bausch And Lomb Inc, was first approved by FDA on Feb 22, 2019, with 0 approved supplements and 0 published complete response letters.
LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 22, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lotemax Sm0.38% · gel;ophthalmic | Loteprednol Etabonate | RxReference drug |
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
