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 Approved Drug Products with Therapeutic Equivalence Evaluations
Orange Book

Orange Book Query (12/22/2008)
The Electronic Orange Book Query enables searching of the approved drug list by active ingredient, proprietary name, applicant holder or applicant number. The data is updated concurrently with the publication of the annual edition or cumulative supplements.

Orange Book Annual Edition (28th Edition) PDF [6.5 MB]  (2/21/2008)
The publication identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act. 

Orange Book Current Cumulative Supplement PDF (12/22/2008)

The monthly Cumulative Supplement publication provides information on newly approved drugs, changes and revisions to current data including therapeutic equivalence evaluations, and updated patent and exclusivity data.

Orange Book - Information and Data Files (12/22/2008)
Text files for importing into databases.

Orange Book Monthly Additions and Deletions (12/22/2008)
Changes to the annual edition are listed separately by month.

PDF requires the free Adobe Acrobat Reader

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Date updated: December 22, 2008

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