Reduces elevated intraocular pressure (IOP). ANDA 78479, held by Apotex. Brimonidine Tartrate.
As of Nov 15, 2026, ANDA 78479 (Brimonidine Tartrate), held by Apotex, was first approved by FDA on Jan 31, 2022, with 1 approved supplement and 0 published complete response letters.
Brimonidine tartrate ophthalmic solution, 0.15% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brimonidine Tartrate0.15% · solution/drops;ophthalmic | Brimonidine Tartrate | Rx |
| May 20, 2026 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jan 31, 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
