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Get to Know About Orange Book

The "Approved Drugs With Therapeutic Equivalency Rating" (a list known as the "Orange Book") identifies drugs approved by the Food and Drug Administration (FDA) of the Federal Food, Drug Administration and Law on the basis of safety and efficacy.

The main criterion for submitting a product is that it is the subject of an application for approval that has not been withdrawn for safety or efficacy reasons. The inclusion of a product in the Orange Book is independent of current regulatory actions being taken in administrative or legal proceedings against the medicinal product.

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In addition, the Orange Book contains reviews of approved drug therapy equivalence from a variety of sources. 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 assessment in this publication is not an official FDA action affecting the legal status of products under the FD&C Act.

On May 31, 1978, the Commissioner for the Food and Drug Administration sent a letter to officials in each state announcing the FDA's intention to provide a list of all FDA-approved prescription drugs for safety and effectiveness. along with determining the therapeutic equivalence for multioriental prescription products.

The Orange Book was circulated as a proposal in January 1979. It contains only prescription drugs currently available that are approved by the FDA through the New Drug Application (NDA) and abbreviated as New Drug Application (YOU) under the provisions of Section 505 of the FD&C Act and FDA regulations at that time.