Thursday, September 4, 2008

FDA Orange Book - Online

FDA Orange Book - Online

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

- -  original post follows below  - -

In case you didn't know, the FDA's Orange Book is now available online. The folks at Foley & Lardner LLP state, "The FDA's Approved Drug Products List with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, was introduced in 1979, and since its introduction has unquestionably been the authoritative reference source for drug products approved by FDA under the Federal Food, Drug & Cosmetic Act. No longer a printed book, but a database available on FDA's website, the Orange Book lists all products that have been approved by FDA for safety and effectiveness, and explains the therapeutic equivalence code for multi-source products." The FDA website makes the following Orange Book resources available to you . . .
  1. 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.
  2. Orange Book Annual Edition (28th Edition) - The publication identifies drug products approved on the basis of safety and effectiveness.
  3. Orange Book 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.
  4. Orange Book - Information and Data Files - Text files for importing into databases.
  5. Orange Book Monthly Additions and Deletions - Changes to the annual edition are listed separately by month.
  6. Frequently Asked Orange Book Questions
  7. Frequently Asked Patent and Exclusivity Questions
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