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Amlodipine/benazepril. Amlodipine/benazepril, marketed in the U.S. as Lotrel by Novartis and manufactured as a generic drug by Teva and Sandoz, is an antihypertensive medication which combines a calcium channel blocker (amlodipine besilate) with an angiotensin converting enzyme inhibitor (benazepril).
December 22, 2011, submitted under section 505(b)(1) of the Federal Food, Drug, and Cosmetic. Act (FDCA) for Lotrel (amlodipine besylate and benazepril hydrochloride) 2.5/10 mg, 5/10 mg, 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets. This âPrior Approvalâ supplemental new drug application provides for labeling revised as. follows: