The publication Approved Drug Products with Therapeutic Equivalence Evaluations (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 Act) and related patent and exclusivity information.
The Orange Book identifies drug products approved by the Food and Drug Administration (FDA) on the basis of safety and effectiveness under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Primarily, included products are the subject of an application with an approval that has not been withdrawn for safety or efficacy reasons. In addition, the Orange Book contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs, although Orange Book equivalence evaluations are not official FDA actions affecting the legal status of products under the FD&C Act. The therapeutic equivalence evaluations in the Orange Book reflect FDA’s application of specific criteria to the multisource prescription drug products listed in the Orange Book and approved under Section 505 of the FD&C Act.
The FDA maintains drugs listed in the Orange Book regardless of any current regulatory action through administrative or judicial means against a drug product. The Orange Book is composed of four parts: (1) approved prescription drug products with therapeutic equivalence evaluations; (2) approved over‑the‑counter (OTC) drug products for those drugs that may not be marketed without NDAs or ANDAs because they are not covered under existing OTC monographs; (3) drug products with approval under Section 505 of the FD&C Act administered by the Center for Biologics Evaluation and Research; and (4) a cumulative list of approved products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing and we have not determined that they were withdrawn for safety or effectiveness reasons, or have had their approvals withdrawn for other than safety or efficacy reasons subsequent to being discontinued from marketing.
Note: This page includes general information from the FDA which is provided for educational purposes only. The advice of an attorney should be sought to obtain legal advice relevant to your particular circumstances.