For open-angle glaucoma or ocular hypertension. NDA 21764, held by Sandoz. Brimonidine Tartrate.
As of Nov 15, 2026, NDA 21764 (Qoliana), held by Sandoz, was first approved by FDA on May 22, 2006, with 6 approved supplements and 0 published complete response letters.
Brimonidine tartrate ophthalmic solution, 0.15% is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2006 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Qoliana0.15% · solution/drops;ophthalmic | Brimonidine Tartrate | RxReference drug |
| Nov 21, 2025 | Supplement 12Labeling · Standard review | Approved | |
| Jan 19, 2016 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Nov 10, 2015 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Sep 25, 2014 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Mar 27, 2012 | Supplement 5Labeling | Approved | |
| Aug 3, 2010 | Supplement 2Labeling · Standard review | Approved | |
| May 22, 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
