Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)

Description

The 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). (For more information, see the Orange Book Preface.)

Resources

Name Format Description Link
57 UCM163762.zip http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM163762.zip

Tags

  • cder
  • orange-book

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