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Definition of Orange Book
Orange Book is a document the US Food and Drug Administration (FDA) maintains that lists all the drugs, prescription and over-the-counter, that have FDA approval for use in the United States.
As of 2005 The Orange Book is available only as an electronic document (www.fda.gov/cder/ob) on the FDA’s Web site (print editions are no longer obtainable). An individual may download the document in a printable format to produce a paper copy, if desired.
The FDA updates the book daily. These updates provide, among other kinds of information, the most current information about newly approved generic products. The book lists drugs by proprietary (trade or brand) name, active ingredient, and patent holder.