Approved Drug Products with Therapeutic Equivalence Evaluations

The Orange Book identifies drugs approved on the basis of safety and efficacy by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetics Act. The publication does not contain any drug on the market that is approved only for safety reasons.

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The main criterion for submitting a product is that it is subject to application with an effective authorization that has not been withdrawn for safety or efficacy reasons. Inclusion of a product on the list does not depend on current official action at the administrative or judicial level against medicinal products.

Additionally, the Orange Book includes a therapeutic equivalence rating (2 symbolic rating codes) for approved multi-source (generic) prescription drugs.

These ratings serve as public information and advice to public health authorities, prescribing authorities and pharmacists to help educate the public about drug choices and reduce health care costs.

The therapeutic equivalence ratings in this publication are not official FDA actions affecting the legal status of products under the law.

Lastly, the Orange Book lists the patents that have been developed to protect drugs. Patent lists and usage codes are provided by the owner of the drug application and the FDA must register them.

The Orange Book does not list organic products such as vaccines. They are included in the list of licensed organic products which are subsequently adopted with reference ratings of exclusivity and biosimilarity or interchangeability known as Purple Books.