PMCT
PharmaCountry
+ Create
EN
Demands
Home
Products
Services
Jobs
Seekers
Home
/
Insights
/
Regulatory Updates
Regulatory Updates
FDA, EMA, TGA and global regulatory developments
#Synthon
×
Daily News
Analysis
Research & Reports
Regulatory Updates
UPDATED
Regulatory Updates
Sep 27, 2026
•
1 min read
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.