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.
規制動向2026年9月27日•1分で読めます
FDA Approves ANDA 077973 for Bicalutamide 50 mg Tablet – Synthon Pharm
FDA approves ANDA 077973 for Synthon Pharm’s 50 mg oral bicalutamide tablet; labeling approved in 2009 and manufacturing in 2011.
PharmaCountryチームがまとめました · 出典： FDA.gov
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