viernes, 20 de julio de 2012

Drug Approvals and Databases > Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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Drug Approvals and Databases > Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)


Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)


About the Orange Book

The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). (For more information, see the Orange Book Preface.)

The Approved Drug Products list first appeared as a print publication in 1980. With the 25th edition (2005), Portable Document Format (PDF) versions of the Annual Edition and the Cumulative Supplement became available.

The Orange Book Search was added to the FDA website October 31, 1997. 
Orange Book with jack-o'-lanterns
Did you ever wonder how the Orange Book got its nickname?
When the first print edition of Approved Drug Products with Therapeutic Equivalence Evaluations was being prepared October 1980, staff members in the Office of Generic Drugs had to choose a color for the cover. The project manager suggested, "It's almost Halloween. How about orange?"
Before long, The Orange Book had become a popular short title for this important publication.
To send comments or questions about the Orange Book or drug data, please see the contact information below.

  • Orange Book Search
    You can search by active ingredient, proprietary name, applicant, or application number.


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Orange Book Publications

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Downloadable Files

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Help and Background Information


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