FDA List of Authorized Generic Drugs
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 name drug ...
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.
Generic Drugs | FDA
Mar 13, 2025 · Understanding generic drugs. Consumer-friendly information on the safe and effective use of generic drugs.
Generic Drug Facts | FDA
Nov 1, 2021 · Generic drugs: Get the facts. Consumer-friendly text and graphics provide a few facts about generic drug approval, quality, and performance.
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 …
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.
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 ...
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 ...
Office of Generic Drugs 2022 Annual Report | FDA
In 2022, generic drugs remained a significant public health priority for the FDA. Competition from generic drug makers helped make drugs more widely available and generally less expensive ...
FDA Announces New ANDA Prioritization Pilot
Oct 3, 2025 · FDA is announcing a new pilot prioritization program for the review of abbreviated new drug applications (ANDAs).