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  2. Generic Drugs: Questions & Answers - FDA

    www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs...

    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 ...

  3. Generic Drug Facts | FDA - U.S. Food and Drug Administration

    www.fda.gov/drugs/generic-drugs/generic-drug-facts

    The active ingredient in the generic medicine is the same as in the brand-name drug/innovator drug. The generic medicine has the same strength, dosage form (such as a tablet or an injectable), and ...

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

    www.fda.gov/drugs/generic-drugs/overview-basics

    Overview & Basics. 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: Use ...

  5. FDA List of Authorized Generic Drugs | FDA - U.S. Food and Drug...

    www.fda.gov/.../fda-list-authorized-generic-drugs

    A generic drug, as that term is commonly understood and referred to by health care providers and insurers, is a copy of a brand-name drug that is developed and made by a company other than the ...

  6. Generic Drugs: What Everyone Should Know | FDA - U.S. Food and...

    www.fda.gov/drugs/resources-drugs/generic-drugs-what-everyone-should-know

    In fact, brand-name firms account for an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.

  7. FDA approves first generic Advair Diskus | FDA - U.S. Food and...

    www.fda.gov/news-events/press-announcements/fda-approves-first-generic-advair...

    January 30, 2019. Español. The U.S. Food and Drug Administration today approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily ...

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

    www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs

    Understanding generic drugs: Consumer-friendly information on the safe and effective use of generic drugs. Learn about the generic drug approval process, why generic drugs are usually less ...

  9. FDA Approves First Generic Pimobendan for Dogs

    www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic...

    Pimomedin contains the same active ingredient (pimobendan) in the same concentration and dosage form as the approved brand name drug product, Vetmedin, which was first approved on April 30, 2007.

  10. Generic Enoxaparin Questions and Answers | FDA

    www.fda.gov/.../generic-enoxaparin-questions-and-answers

    The currently available brands of LMWH approved by FDA in the United States are: Lovenox generic name, enoxaparin manufactured by Sanofi-Aventis. Fragmin generic name, dalteparin manufactured by ...

  11. The Generic Drug Approval Process - FDA

    www.fda.gov/drugs/cder-conversations/generic-drug-approval-process

    Generic drugs are copies of innovator or brand-name prescription drugs and make up about 90 percent of prescriptions filled in the United States. Brand-name drugs must demonstrate their safety and ...