Definition of Orange Book

orange book the documentOrange 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.

Listings identify the INNOVATOR DRUG (first drug that received approval) and any GENERIC DRUG also approved for use as well as provide information about the status of the product’s patent.

See also FORMULARYINVESTIGATIONAL NEW DRUG (IND).

Orange Book, The – FDA Document
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