Reduces elevated intraocular pressure (IOP). NDA 21994, held by Sandoz. Travoprost.
As of Nov 14, 2026, NDA 21994 (Travatan Z), held by Sandoz, was first approved by FDA on Sep 21, 2006, with 6 approved supplements and 0 published complete response letters.
TRAVATAN Z (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
| Aug 31, 2010 | Supplement 1Efficacy (new indication or use) | Approved | |
| Sep 21, 2006 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Travatan Z0.004% · solution/drops;ophthalmic | Travoprost | RxReference drug |
| Oct 9, 2025 | Supplement 20Labeling · Standard review | Approved | |
| Apr 2, 2020 | Supplement 13Labeling · Standard review | Approved | |
| Sep 22, 2017 | Supplement 12Labeling · Standard review | Approved | |
| Mar 11, 2016 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Sep 7, 2011 | Supplement 6Labeling | Approved | |
| Aug 31, 2010 | Supplement 1Efficacy (new indication or use) | Approved | |
| Sep 21, 2006 | Original applicationNew formulation or manufacturer · Standard review | 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
