The Orange Book is continuously updated electronically, and new editions are not published in hard copy on a set schedule like some printed publications. The information in the Orange Book is updated in two ways-on its website and in print publications that are also available as downloadable PDFs. Website updates occur on a daily, semi-monthly, monthly, and annual basis. Print updates occur on a monthly and annual basis. It is usually updated with new drug approvals, withdrawals, therapeutic equivalence evaluations, and related information as they occur.

The Orange Book contain information about: (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 covered under existing OTC monographs; (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for exportation, are for military use, have been discontinued from marketing and we have not determined that they were withdrawn from sale for safety or effectiveness reasons, or have had their approvals withdrawn for other than safety or efficacy reasons subsequent to being discontinued from marketing.

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