Reduces elevated intraocular pressure (IOP). ANDA 216772, held by Upsher Smith Labs. Brimonidine Tartrate.
As of Nov 15, 2026, ANDA 216772 (Brimonidine Tartrate), held by Upsher Smith Labs, was first approved by FDA on Jun 12, 2024, with 1 approved supplement and 0 published complete response letters.
Brimonidine tartrate ophthalmic solution 0.15% is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brimonidine Tartrate0.15% · solution/drops;ophthalmic | Brimonidine Tartrate | Rx |
| Jun 5, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 12, 2024 | 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
