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Al Harris Library FDA Orange Book


Citing Sources


The Orange Book identifies drug products approved on the basis of safety and effectiveness by the FDA. (Note that drugs approved only on the basis of safety are not included.) The Orange Book also contains therapeutic equivalence evaluations for multisource prescription drugs. Searchable the Orange Book by active ingredient, proprietary name, applicant holder, or application number.

  • No restrictions; available to everyone.
  • Simultaneous users: unlimited
  • Publisher: U.S. Food and Drug Administration