What is the FDA Orange Book?

• A. A catalog of brand-name drug approvals
• B. A registry of adverse drug reactions
• C. A database for pharmaceutical manufacturing licensing
• D. A catalog of generic drug approvals

Answer: (D)

The FDA Orange Book is the official directory of approved drug products with therapeutic equivalence evaluations. It focuses on which generic drugs have FDA-approved equivalents to brand-name products and whether those generics are interchangeable, based on having the same active ingredient, strength, and dosage form. This makes it the go-to resource for identifying generic approvals and substitution possibilities. It’s not a registry for adverse drug reactions, nor a database for manufacturing licensing. Those areas are covered by other FDA resources.