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Frequently Asked Questions

How can I search the Orange Book?

The Orange Book Appendices are available in PDF format. You can search by active ingredient, proprietary name, applicant, or application number. The active ingredient (s) for the product.

How can the Orange Book help me find information about FDA-approved drugs?

The Electronic Orange Book (EOB) Query enables searching of the approved drug list by active ingredient, proprietary name, applicant holder, applicant number or patent. The Approved Drug Products EOB Query web files are downloadable. The files are ASCII text tilde (~) delimited. They are zipped into a self-extracting file, EOBZIP.ZIP.

What is the purpose of the FDA Orange Book?

The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information.

How often is the Orange Book updated?

The Orange Book downloadable data files are updated monthly. We make every effort to prevent errors and discrepancies in the Approved Drug Products data files; however, if you wish to report an error or discrepancy in drug data, please send a brief description of the problem to [email protected]


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