Regulatory UpdatesSep 27, 2026•1 min read

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

By the PharmaCountry team

FDA approves ANDA 077973 for Synthon Pharm’s 50 mg oral bicalutamide tablet; labeling approved in 2009 and manufacturing in 2011.

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.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#bicalutamide #generic #ANDA #FDA #Synthon #tablet