Reduces elevated intraocular pressure (IOP). ANDA 78480, held by Apotex. Brimonidine Tartrate.
As of Nov 15, 2026, ANDA 78480 (Brimonidine Tartrate), held by Apotex, was first approved by FDA on Dec 21, 2022, with 1 approved supplement and 0 published complete response letters.
Brimonidine tartrate ophthalmic solution 0.1% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 21, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brimonidine Tartrate0.1% · solution/drops;ophthalmic | Brimonidine Tartrate | Rx |
| May 20, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 21, 2022 | Original application | Approved | None posted |
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
