For open-angle glaucoma or ocular hypertension. ANDA 217846, held by Micro Labs. Brimonidine Tartrate.
As of Nov 15, 2026, ANDA 217846 (Brimonidine Tartrate), held by Micro Labs, was first approved by FDA on Nov 22, 2023, with 0 approved supplements and 0 published complete response letters.
Brimonidine tartrate ophthalmic solution 0.2% is indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of brimonidine tartrate ophthalmic solution diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 22, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brimonidine Tartrate0.2% · 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
