The Office of Generic Drugs publishes a list of first-time approvals to manufacture generic drugs and a variety of reports on generic drug application activities to provide public insight into communications between FDA and industry.

First Generic Drug Approvals
First-time FDA approvals of generics of brand-name drug products

Competitive Generic Therapy 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 Performance)
• FDARA Quarterly Report of Generic Drugs Program Activities (additional FDARA reports available here)
• GDUFA Quarterly Report of the Generic Drugs Program Activities
• GDUFA Section 903 Quarterly Report of Generic Drugs Guidances and Public Meetings

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