FDA Approves ANDA078395 for Dorzolamide Hydrochloride Ophthalmic Solution

The U.S. Food and Drug Administration has approved Abbreviated New Drug Application (ANDA) number 078395 for Dorzolamide Hydrochloride ophthalmic solution 2% (EQ 2% BASE). The product is a prescription eye‑drop marketed by Advagen Pharma Ltd., with Rubicon Research listed as the sponsor. The drug is classified as a human prescription drug, administered via the ophthalmic route in a solution/drops dosage form. It carries package NDC 72888-077-15 and contains the active ingredient Dorzolamide Hydrochloride at a strength of 2%. The approval timeline includes an original submission (ORIG) on 2008‑10‑28, followed by labeling supplement approvals on 2011‑01‑28 (submission 4), 2015‑11‑27 (submission 8), and 2021‑12‑03 (submission 10). All submissions received an approved (AP) status, with standard review priority for labeling updates.