FDA Approves ANDA 077780 for Carvedilol Tablets by TARO

The U.S. Food and Drug Administration released an approval letter (dated September 7, 2007) for ANDA 077780 submitted by TARO. The application covers four oral tablet products containing carvedilol at strengths of 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg. Each product is listed with a product number (001, 002, 003, 004) and is classified as a generic (reference drug: No) with no reference standard. All four products are currently marked as discontinued in the FDA database. The original submission (submission number 1) received an approval status (AP) on September 5, 2007, and the approval letter is available through the FDA’s public docket. For full details, see the FDA approval letter: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077780s000_ltr.pdf