Orange Book

The Orange Book contains Approved Drug Products With Therapeutic Equivalence Evaluations, 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 FD&C Act).

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 subject to 505G;

(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for exportation, are for military use, have been discontinued from marketing and we have not determined that they were withdrawn from sale for safety or effectiveness reasons, or have had their approvals withdrawn for other than safety or effectiveness reasons subsequent to being discontinued from marketing.

Frequently Asked Questions Of Orange Book

What Is The Orange Book?

The Orange Book, officially known as the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, lists approved prescription drugs and their therapeutic equivalence.

Why Is The Orange Book Important?

The Orange Book is crucial for healthcare professionals, providing a reliable source for drug efficacy and safety, as well as information on generic drug substitutions.

How Often Is The Orange Book Updated?

The FDA updates the Orange Book frequently, typically monthly, to ensure it reflects current drug approvals and therapeutic evaluations.

Can Consumers Use The Orange Book?

Yes, consumers can use the Orange Book to educate themselves about prescription drug options and generic alternatives.

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