NDA 200738, held by Bausch And Lomb. Loteprednol Etabonate.
As of Nov 13, 2026, NDA 200738 (Lotemax), held by Bausch And Lomb, was first approved by FDA on Apr 15, 2011, with 1 approved supplement and 0 published complete response letters.
LOTEMAX (loteprednol etabonate ophthalmic ointment) 0.5% ointment is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2011 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lotemax0.5% · ointment;ophthalmic | Loteprednol Etabonate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 8, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Apr 15, 2011 | Original applicationNew dosage form · Standard review | Approved |
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
