Reduces elevated intraocular pressure (IOP). ANDA 206519, held by Eugia Pharma. Latanoprost.
As of Nov 15, 2026, ANDA 206519 (Latanoprost), held by Eugia Pharma, was first approved by FDA on Sep 3, 2019, with 2 approved supplements and 0 published complete response letters.
Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 3, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Latanoprost0.005% · solution/drops;ophthalmic | Latanoprost | Discontinued |
| Oct 10, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 10, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 3, 2019 | Original application | Approved | None posted |
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
