Reduces elevated intraocular pressure (IOP). ANDA 218257, held by Gland. Latanoprost.
As of Nov 15, 2026, ANDA 218257 (Latanoprost), held by Gland, was first approved by FDA on Nov 26, 2024, with 0 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 |
|---|---|---|---|
| Nov 26, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Latanoprost0.005% · solution/drops;ophthalmic | Latanoprost | Rx |
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
