The publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the List, 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 FD&C Act). The main criterion for the inclusion of any product is that the product is the subject of an application with an approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products in the Orange Book is independent of any current regulatory action through administrative or judicial means against a drug product.
Information and advice to state health agencies, prescribers, and pharmacists to promote public education.
