What is the purpose of the FDA’s Orange Book?

• A. To identify approved drug products and their therapeutic equivalence (TE) ratings
• B. To list all investigational drugs
• C. To provide labeling for biologics
• D. To register medical devices

Answer: (A)

The main idea here is that the Orange Book is a FDA reference that lists approved drug products and their therapeutic equivalence evaluations. This resource helps pharmacists decide whether a generic version can be substituted for a brand-name product without compromising safety or effectiveness. A product that has a therapeutic equivalence designation is expected to produce the same clinical effect and safety profile as the reference product when used the same way, which supports interchangeability. The Orange Book focuses on small‑molecule drugs and their TE status; it does not list investigational drugs, provide labeling for biologics, or register medical devices.