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Treats elevated intraocular pressure. ANDA 216654, held by Somerset. Timolol.
As of Nov 13, 2026, ANDA 216654 (Timolol), held by Somerset, was first approved by FDA on Oct 10, 2024, with 0 approved supplements and 0 published complete response letters.
First approved: Oct 10, 2024
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE Timolol ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
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
