For open-angle glaucoma or ocular hypertension. ANDA 91691, held by Regcon Holdings. Brimonidine Tartrate.
As of Nov 15, 2026, ANDA 91691 (Brimonidine Tartrate), held by Regcon Holdings, was first approved by FDA on Nov 18, 2014, with 1 approved supplement and 0 published complete response letters.
Brimonidine tartrate ophthalmic solution, 0.2% is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of Brimonidine tartrate ophthalmic solution, 0.2% 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. Brimonidine Tartrate Ophthalmic Solution, 0.2% is an alpha adrenergic agonist indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 2014 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brimonidine Tartrate0.2% · solution/drops;ophthalmic | Brimonidine Tartrate | Rx |
| Jun 22, 2026 | Supplement 7Manufacturing | Approved | None posted |
| Nov 18, 2014 | 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
