FDA Approves ANDA079186 for Dorzolamide Hydrochloride Ophthalmic Solution

The U.S. Food and Drug Administration has approved application ANDA079186 for a generic ophthalmic solution of Dorzolamide Hydrochloride. The product, submitted by AM Regent, is a 2% base solution intended for eye drops. The original ANDA (submission 1) received approval on November 18, 2009. A supplemental labeling submission (submission 3) was later approved on March 25, 2020 under standard review priority. The product is listed as discontinued and is not designated as a reference drug. Key details include the product number 001, dosage form as solution/drops, and the active ingredient Dorzolamide Hydrochloride at an equivalent strength of 2% base.