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Drug Approvals and Databases | FDA

    https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases
    Purple Book (database of FDA-licensed (approved) biological products, including biosimilar and interchangeable products) More Information Wholesale Distributor and Third-Party Logistics...

Is It Really 'FDA Approved'? - U.S. Food and Drug …

    https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved
    Be aware that compounded drugs are not FDA approved. This means that the FDA does not conduct premarket review for compounded drugs to evaluate their …

About Drugs@FDA | FDA - U.S. Food and Drug …

    https://www.fda.gov/drugs/drug-approvals-and-databases/about-drugsfda
    Drugs@FDA includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other information are available …

Development & Approval Process | Drugs | FDA

    https://www.fda.gov/drugs/development-approval-process-drugs
    FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its …

Everything you always wanted to know about approved …

    https://www.fda.gov/drugs/special-features/everything-you-always-wanted-know-about-approved-medicines-didnt-know-where-look
    By using the Drugs@FDA database, you can search for information about FDA-approved brand name and generic drugs and therapeutic biological products. The database …

Unapproved Drugs | FDA - U.S. Food and Drug …

    https://www.fda.gov/drugs/enforcement-activities-fda/unapproved-drugs

    Novel Drug Approvals for 2022 | FDA - U.S. Food and …

      https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022
      Dec 1, 2022

    How are drugs approved for use in the United States?

      https://www.nichd.nih.gov/health/topics/pharma/conditioninfo/approval
      FDA-approved generic drugs meet the same strict standards for safety, efficacy, and quality as name-brand drugs. 2 Consumers usually can buy generic drugs …

    FDA approved vs. FDA cleared: Why you need to know …

      https://www.cnet.com/health/fda-approved-vs-fda-cleared-whats-the-difference/
      What products need to be FDA approved? FDA approval is usually mandatory to market or sell products in the US that might have a significant risk of injury or illness, but can also benefit...

    New FDA Drug Approvals for 2023 - Drugs.com

      https://www.drugs.com/newdrugs.html
      FDA Alerts The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved. See also: Generic …



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