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U.S. Department of Health and Human Services

Drugs

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Generic Drug Review Process

A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.  An important part of CDER's mission is to assure that safe and effective generic drugs are available to the American people.  This work is accomplished in CDER's Office of Generic Drugs (OGD).  The information below provides an understanding of how CDER works to assure the safety and effectiveness of generic drug products. For more information on generic drug applications, please see the Generic Drug Applications web page.