Reduces elevated intraocular pressure (IOP). ANDA 217599, held by Upsher Smith Labs. Brimonidine Tartrate.
As of Nov 15, 2026, ANDA 217599 (Brimonidine Tartrate), held by Upsher Smith Labs, was first approved by FDA on Jul 30, 2025, with 0 approved supplements and 0 published complete response letters.
Brimonidine tartrate ophthalmic solution 0.1% is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 30, 2025 | 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
