FDA Approves Oxford Generic Amlodipine Besylate Tablets (ANDA078414)

The U.S. Food and Drug Administration has approved application ANDA078414 for generic amlodipine besylate tablets submitted by Oxford Pharmaceuticals, LLC. The approval covers three oral tablet strengths: 2.5 mg, 5 mg, and 10 mg. All three products are classified as prescription human drugs and are marketed under the brand names AMLODIPINE BESYLATE 2.5 MG, AMLODIPINE BESYLATE 5 MG, and AMLODIPINE BESYLATE 10 MG. The tablets are intended for oral administration and contain amlodipine besylate as the active ingredient, expressed as equivalent base strengths. The original ANDA received approval on April 7, 2010. Subsequent labeling submissions were approved on April 30, 2010; September 18, 2015; and April 2, 2018, reflecting updates to product labeling over time.