Approvals & Reports

The Office of Generic Drugs publishes a variety of lists and reports on generic drug application activities for public awareness, including:

• First Generic Drug Approvals
  First-time FDA approvals of generics of brand-name drug products
   
• Competitive Generic Therapy (CGT) Approvals
  FDA approvals of CGT-designated drug products
   
• Activities Metrics
  Data on the review and application activities of FDA’s Office of Generic Drugs
  • Report of the Generic Drugs Program (Monthly and Quarterly Performance)
  • FDARA Quarterly Report of Generic Drugs Program Activities (additional FDARA reports available here)
     
• Annual Reports
  Yearly publication of the accomplishments of FDA’s Office of Generic Drugs
   
• FDA List of Authorized Generic Drugs
  Approved, brand-name drugs that are marketed without the brand-name on the label