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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)
[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
(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.
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Date updated: December 22, 2008
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