Treats elevated intraocular pressure (IOP). ANDA 211914, held by Padagis US. Brinzolamide.
As of Nov 15, 2026, ANDA 211914 (Brinzolamide), held by Padagis US, was first approved by FDA on Jul 28, 2023, with 0 approved supplements and 0 published complete response letters.
Brinzolamide ophthalmic suspension is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. Brinzolamide ophthalmic suspension is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brinzolamide1% · suspension/drops;ophthalmic | Brinzolamide | Discontinued |
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
