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orange bookThe publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, 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).

The Approved Drug Products list first appeared as a print publication in October 1980. With the 25th edition (2005), Portable Document Format (PDF) versions of the Annual Edition and the Cumulative Supplement became available.

You can search by active ingredient, proprietary name, applicant, application number, or patent number.

Searching the Orange Book is now faster and easier with the new mobile app!

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