FDA Approves Carvedilol Generic (ANDA 076649) by Dr. Reddy's Laboratories

The U.S. Food and Drug Administration has approved Abbreviated New Drug Application (ANDA) 076649 for carvedilol tablets manufactured by Dr. Reddy's Laboratories Limited. The approval applies to oral tablets intended for prescription use. The approved product is marketed under the brand name CARVEDILOL and is available in four tablet strengths: 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg. All formulations are oral tablets and are classified as human prescription drugs. The FDA submission record shows a series of labeling submissions: submission number 4 (January 30 2009), number 6 (February 18 2010), and number 8 (May 7 2013), each receiving an “AP” (approved) status. The original application was accompanied by a letter dated September 7 2007. Dr. Reddy's Laboratories Limited is listed as the manufacturer, and the product is identified with multiple NDC codes under the CARVEDILOL brand.