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  1. Generic Drugs

Approvals & Reports

A stack of reportsThe 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

Annual Reports
Yearly publication of the accomplishments of FDA’s Office of Generic Drugs

FDA List of Authorized Generic Drugs
Industry Resources Find Resoruces to help with ANDA applicationsApproved, brand-name drugs that are marketed without the brand-name on the label

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