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  1. Generic Drugs

Approvals & Reports

A stack of reportsTo provide public insight into communications between FDA and industry, 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 reviews.

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

Activities Metrics
Data on the review and application activities of FDA’s Office of Generic Drugs

Dashboard Reports
Updates on the ongoing review communications between FDA and industry, including the proportion of generic drug applications awaiting FDA review or response by industry

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

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