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  1. fda.gov
    https://www.fda.gov › drugs › information-consumers-and-patients-drug…

    Find Information about a Drug | FDA

    Find Drug Information on MedlinePlus Easy-to-use resource from NIH with information about side effects, dosage, special precautions, and more for prescription and OTC drugs

  2. fda.gov
    https://www.fda.gov › drugs › novel-drug-approvals-fda

    Novel Drug Approvals for 2025 | FDA

    Dec 17, 2025 · Novel Drug Approvals for 2025 What are "Novel" Drugs? "Novel" drugs are new drugs never before approved or marketed in the U.S.

  3. fda.gov
    https://www.fda.gov › drugs › guidance-compliance-regulatory-informatio…

    Electronic Drug Registration and Listing System (eDRLS) | FDA

    Companies who list OTC monograph drugs should update their drug listings accordingly as part of the annual establishment registration renewal and drug listing certification period that begins …

  4. fda.gov
    https://www.fda.gov › drugs › drug-approvals-and-databases › national-d…

    National Drug Code Directory | FDA

    Drug establishments are required to provide FDA with a current list of all drugs manufactured, prepared, propagated, compounded or processed for sale in the U.S. at their facilities.

  5. fda.gov
    https://www.fda.gov › drugs

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

    The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States

  6. fda.gov
    https://www.fda.gov › drugs › drug-approvals-and-databases › approved …

    Approved Drug Products with Therapeutic Equivalence Evaluations ...

    Dec 12, 2025 · FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) identifies drug products approved on the basis of safety and effectiveness.

  7. fda.gov
    https://www.fda.gov › drugs › drug-interactions-labeling › healthcare-prof…

    Update HCP Drug Interactions

    Jun 27, 2025 · FDA’s Examples of Interacting Drugs and Other Substances Involving CYP Metabolic- and Transporter System-Based Pathways for Healthcare Professionals

  8. fda.gov
    https://www.fda.gov › drugs › human-drug-compounding › bulk-drug-sub…

    Bulk Drug Substances Used in Compounding Under Section 503B

    Jan 7, 2025 · These bulk drug substances can be re-nominated with sufficient supporting information through Bulk Drug Substances That Can Be Used To Compound Drug Products in …

  9. fda.gov
    https://www.fda.gov › drugs › novel-drug-approvals-fda

    Novel Drug Approvals for 2024 | FDA

    Jul 14, 2025 · FDA Novel Drug Therapy Approvals for 2024: FDA Novel Drug Therapy Approvals for 2024 In 2024, CDER approved 50 new drugs never before approved or marketed in the …

  10. fda.gov
    https://www.fda.gov › drugs › drug-approvals-and-databases › drug-trial…

    Drug Trials Snapshots | FDA

    Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent.

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