Reduces elevated intraocular pressure (IOP). ANDA 218558, held by Micro Labs. Brimonidine Tartrate.
As of Nov 15, 2026, ANDA 218558 (Brimonidine Tartrate), held by Micro Labs, was first approved by FDA on May 7, 2026, with 0 approved supplements 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 |
|---|---|---|---|
| May 7, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brimonidine Tartrate0.1% · solution/drops;ophthalmic | Brimonidine Tartrate | Rx |
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
