For open-angle glaucoma or ocular hypertension. ANDA 209040, held by Sandoz. Tafluprost.
As of Nov 15, 2026, ANDA 209040 (Tafluprost), held by Sandoz, was first approved by FDA on Jan 28, 2022, 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 |
|---|---|---|---|
| Jan 28, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tafluprost0.0015% · solution/drops;ophthalmic | Tafluprost | Rx |
| Oct 8, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 28, 2022 | 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
