What is the “orange book” put out by the FDA?


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.  On its website, the FDA explains that the main criterion for the inclusion of any product is that it is the subject of an application with an approval that has not been withdrawn for safety or efficacy reasons.  For more on the Orange Book, go to


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