NDA 20583, held by Bausch And Lomb. Loteprednol Etabonate.
As of Nov 13, 2026, NDA 20583 (Lotemax), held by Bausch And Lomb, was first approved by FDA on Mar 9, 1998, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Loteprednol etabonate ophthalmic suspension is indicated for the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 9, 1998 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lotemax0.5% · suspension/drops;ophthalmic | Loteprednol Etabonate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 2013 | Supplement 28Manufacturing · Standard review | Approved | |
| Oct 9, 2013 | Supplement 27Manufacturing · Standard review | Approved | |
| Jul 11, 2006 | Supplement 13Manufacturing | Approved | None posted |
| Aug 30, 2001 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 18, 2000 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Aug 17, 1999 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| May 19, 1999 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 9, 1998 | Original applicationNew molecular entity · 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
