NDA 210565, held by Alcon Labs Inc. Loteprednol Etabonate.
As of Nov 13, 2026, NDA 210565 (Inveltys), held by Alcon Labs Inc, was first approved by FDA on Aug 22, 2018, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 22, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Inveltys1% · suspension/drops;ophthalmic | Loteprednol Etabonate | DiscontinuedReference drug |
| Apr 24, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Aug 22, 2018 | Original applicationNew formulation or manufacturer · 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
