Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
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 (FD&C Act) and related patent and exclusivity information.
"The Orange Book is composed of four parts:
- approved prescription drug products with therapeutic equivalence evaluations;
- 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;
- drug products with approval under Section 505 of the FD&C Act administered by the Center for Biologics Evaluation and Research; and
- 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for exportation, are for military use, have been discontinued from marketing and we have not determined that they were withdrawn for safety or effectiveness reasons, or have had their approvals withdrawn for other than safety or efficacy reasons subsequent to being discontinued from marketing.1
This publication also includes indices of prescription and OTC drug products by trade name (proprietary name) or established name (if no trade name exists) and by applicant name (holder of the approved application), which have been abbreviated for this publication."
1Newly approved products are added to parts 1, 2, or 3, of the Orange Book, depending on the dispensing requirements (prescription or OTC) or approval authority, unless the Orange Book staff is otherwise notified before publication.