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  1. Generic Drugs: Questions & Answers | FDA

    A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and ...

  2. Generic Drugs | FDA - U.S. Food and Drug Administration

    Mar 13, 2025 · Understanding generic drugs. Consumer-friendly information on the safe and effective use of generic drugs.

  3. 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.

  4. Generic Drug Facts Generic medicines are the same high quality as their brand-name versions. Generic drugs go through a rigorous review process to receive FDA approval.

  5. Overview & Basics | FDA - U.S. Food and Drug Administration

    Sep 16, 2025 · Generic Drug Facts Facts about generic medicines, including review standards, cost, exclusivities, and other related topics What Is the Approval Process for Generic Drugs?

  6. 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 ...

  7. Fiscal Year 2025 Generic Drug Science and Research Initiatives Public ...

    Aug 6, 2025 · Members of the generic drug industry, scientists/researchers, clinicians, regulatory affairs professionals, and patient advocates who work on or are interested in research that advances the ...

  8. What Is the Approval Process for Generic Drugs? | FDA

    The generic drug needs to show that it is the same type of product (such as a tablet or an injectable) and uses the same time release technology (such as immediate-release, meaning for immediate ...

  9. Office of Generic Drugs 2023 Annual Report | FDA

    Mar 4, 2024 · Office of Generic Drugs 2023 Annual Report (PDF - 1 MB) In 2023 generic drugs continued to play a critical role in the U.S. health care system allowing patients greater access to …

  10. Product-Specific Guidances for Generic Drug Development

    Mar 26, 2025 · Increased transparency on product-specific guidances gives applicants seeking to develop generic drugs a better opportunity to efficiently allocate resources.