Generic Drugs: Questions & Answers | FDA
Generic Drug Facts At-a-glance information on generic medicines, including why they may look different or cost less than brand-name medicines.
FDA List of Authorized Generic Drugs
Jan 8, 2026 · The FDA List of Authorized Generics page answers what an authorized generic is and how it differs from a traditional generic. An authorized generic is used to describe an approved brand …
Overview & Basics | FDA
Sep 16, 2025 · The FDA Office of Generic Drugs follows a rigorous review process to make sure that, compared to the brand-name (or innovator) medications, the proposed generic medications: Contain …
Generic Drugs | FDA
Mar 13, 2025 · Understanding generic drugs. Consumer-friendly information on the safe and effective use of generic drugs.
Generic drugs go through a rigorous review process to receive FDA approval. The FDA ensures a generic medication provides the same clinical benefit and is as safe and efective as the brand-name ...
U.S. Food and Drug Administration
U.S. Food and Drug Administration
This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications ...
First Generic Drug Approvals | FDA
Oct 23, 2025 · FDA considers first generics to be important to public health, and prioritizes review of these submissions.
Office of Generic Drugs 2022 Annual Report | FDA
The approval of generics often means that there are multiple manufacturers for a drug product, which also helps stabilize the supply of medicines and reduces the risk of drug shortages.
Complex Generics News | FDA
Nov 22, 2024 · Generics of complex brand name drugs (i.e., reference listed drugs) can be more difficult to develop. As such, a complex drug may be less likely to have an available generic.