For open-angle glaucoma or ocular hypertension. ANDA 208992, held by Somerset Theraps LLC. Brimonidine Tartrate.
As of Nov 15, 2026, ANDA 208992 (Brimonidine Tartrate), held by Somerset Theraps LLC, was first approved by FDA on Mar 11, 2019, with 0 approved supplements and 0 published complete response letters.
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 |
|---|---|---|---|
| Mar 11, 2019 | 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
