FDA Approves ANDA 077973 for Bicalutamide 50 mg Tablet – Synthon Pharm

Synthon Pharm has received FDA approval for an Abbreviated New Drug Application (ANDA) numbered 077973 covering a 50 mg oral tablet of bicalutamide. The product is listed as a discontinued marketed tablet. The FDA’s approval sequence includes an original submission (submission #1) with labeling documents approved on July 6 2009, a supplemental manufacturing (CMC) submission (submission #2) approved on January 7 2011, and a supplemental labeling submission (submission #3) approved on April 26 2011.