The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration (FDA) today launched an improved web-based version of the Approved Drug Products with Therapeutic Equivalence Evaluations – most commonly known as the “Orange Book.” This is the first major revision of the web page and features an updated design with new, user-friendly search options that help users customize their research experience.
The redesigned Orange Book web page conveniently collects search and browse options onto the home page to improve access of these commonly used features. Groups of “accordion” panels open to reveal new and enhanced features and contact information.
The Orange Book, which identifies drug products approved on the basis of safety and effectiveness by the FDA, first appeared as a published list in October 1980. Since 1984, the Orange Book has also included information about patents and exclusivity for listed products. In 1997, the FDA made the Orange Book database available for searching on the Web. Today, “Orange Book” is one of the most searched-for terms on FDA.gov.
This web page update is the latest in a series of FDA efforts to improve the agency’s online presence with the latest technologies and best practices. The new Orange Book web page, along with last year’s Drug Shortages and Orange Book web applications, shows the agency’s commitment to developing effective means for the public to access important and useful information.