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The Orange Book: Understanding Therapeutic Equivalence and Generic Drug Substitution

  • December 24 2025
  • Rowena Calderwood
  • Health & Wellness
  • 10 comment
The Orange Book: Understanding Therapeutic Equivalence and Generic Drug Substitution

The Orange Book is the FDA's official guide to therapeutic equivalence between brand-name and generic drugs. It determines which generics can be safely substituted, saving billions in healthcare costs while ensuring patient safety.

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