Reduces elevated intraocular pressure (IOP). ANDA 216909, held by Alembic. Brimonidine Tartrate.
As of Nov 15, 2026, ANDA 216909 (Brimonidine Tartrate), held by Alembic, was first approved by FDA on Aug 1, 2023, 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 |
|---|---|---|---|
| Aug 1, 2023 | 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
