Approved Drug Products with Therapeutic Equivalence
Orange Book Query
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)
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.
Current Cumulative Supplement
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
Text files for importing into databases.
Orange Book Monthly Additions and
Changes to the annual edition are listed separately by month.
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Back to Drug Information
Date updated: September 12, 2008