Drug Information Update- New Orange Book Mobile Application

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

FDA has launched a mobile application (app) to put timely information about generic drugs in the hands of those using smartphones and tablets. The new app makes it easy and convenient to view The Approved Drug Products with Therapeutic Equivalence Evaluations list. This list is most commonly known as the “Orange Book.”

The Orange Book Express mobile app provides users with a mobile-friendly way to identify drug products approved on the basis of safety and effectiveness by the Agency, as well as information about patents and exclusivity. It allows them to search both the Active Ingredient and Proprietary Name fields at once, without searching separately for each marketing status for prescription, over-the-counter, and discontinued products. Users can also search by patent number without specifying a marketing status. The app will differ from the full Web version of the Orange Book in that the ability to filter results and search for text within results will be unavailable via data download.

Orange Book users include pharmacists, prescribers, industry, Agency employees, and third-party payers. Industry personnel refer to the Orange Book for its patent pages and product-specific exclusivity information, and to determine reference standards or drugs for performing their bioequivalence studies. Third-party payers, pharmacists, and prescribers use the Orange Book to determine appropriate generic drug substitution.

The Orange Book first appeared as a print publication in October 1980. Today “Orange Book” is one of the most searched-for terms on FDA.gov.

The Orange Book Express mobile app reflects our commitment to keep up with the latest technologies, developing effective means for the public to access important and useful information about generic drugs. The app also makes the Orange Book available to a wider audience than ever before – supporting users who may not always have convenient access to a computer or wired Internet connection.

For more information about the new mobile app, including links for free download via iTunes or Google Play Store, visit Orange Book.