jueves, 28 de septiembre de 2017

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

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

Orange Book 2.0  New Look, New Features

Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)


The Orange Book

The publication Approved Drug Products with Therapeutic Equivalence Evaluations (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) and related patent and exclusivity information. For more information on the Orange Book including its history, see the Orange Book Preface.
Search the Orange Book Database
Search approved drug products by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number.
Special Note for Mobile App Users: Orange Book Express will be removed from Google Play and the App Store at the end of June. Please uninstall the old app and download Orange Book Express 2.0.
  • Search results and drug listings now clarify which listed drugs are reference listed drugs (RLDs) and which are reference standards.
  • The new app uses HTTPS encryption to provide a secure connection.













































Orange Book Publications

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