For open-angle glaucoma or ocular hypertension. ANDA 209051, held by Micro Labs. Tafluprost.
As of Nov 15, 2026, ANDA 209051 (Tafluprost), held by Micro Labs, was first approved by FDA on Aug 19, 2019, with 1 approved supplement and 0 published complete response letters.
Tafluprost ophthalmic solution is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tafluprost0.0015% · solution/drops;ophthalmic | Tafluprost | Rx |
| Oct 8, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 19, 2019 | Original application | 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
