Reduces elevated intraocular pressure (IOP). ANDA 219306, held by Micro Labs. Latanoprost.
As of Nov 15, 2026, ANDA 219306 (Latanoprost), held by Micro Labs, was first approved by FDA on Apr 14, 2025, 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 |
|---|---|---|---|
| Apr 14, 2025 | 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
