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  1. 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.

  2. First Generic Drug Approvals | FDA

    Oct 23, 2025 · FDA considers first generics to be important to public health, and prioritizes review of these submissions.

  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. 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 …

  5. 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 …

  6. FDA Roundup: March 4, 2025

    Mar 4, 2025 · On Monday, the FDA approved the first generics of Xarelto (rivaroxaban), 2.5 mg, tablets to reduce the risk of major cardiovascular events in adult patients with coronary artery …

  7. Generic Drugs Forum (GDF) 2025 - 04/09/2025 | FDA

    Dec 20, 2024 · Join us at the annual Generic Drugs Forum, a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generics.

  8. Generic Drugs Undergo Rigorous FDA Review | FDA

    FDA-approved generic drugs, like their brand counterparts, have met strict approval standards. About 9 in 10 prescriptions filled in the U.S. are for generics.

  9. 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 …

  10. Approved Drug Products with Therapeutic Equivalence Evaluations ...

    5 days ago · FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) identifies drug products approved on the basis of safety and effectiveness.