Drug Approvals and Databases > Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

Drug Approvals and Databases > Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

The Orange Book

The publication Approved Drug Products with Therapeutic Equivalence Evaluations (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) and related patent and exclusivity information. For more information on the Orange Book including its history, see the Orange Book Preface.

Search the Orange Book Database
Search approved drug products by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number.

FDA introduces reference standard data updates to the Orange Book 

Special Note for Mobile App Users: Orange Book Express will be removed from Google Play and the App Store at the end of June. Please uninstall the old app and download Orange Book Express 2.0.

• Search results and drug listings now clarify which listed drugs are reference listed drugs (RLDs) and which are reference standards.
• The new app uses HTTPS encryption to provide a secure connection.

Orange Book Publications

• Orange Book Annual Edition (PDF - 8.4MB) 
  37th 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.
• Orange Book Current Cumulative Supplement (PDF - 3MB) 
  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.
• Appendix A: Product Name Index (PDF - 167KB) 
  Prescription and OTC drug product lists. An index of drug products by established or trade name. Updated quarterly.
• Appendix B: Product Name Sorted by Applicant (PDF - 394KB) 
  Product Name Index listed by Applicant (prescription and OTC product lists). Cross-references applicants to drug products. Updated quarterly.
• Appendix C: Uniform Terms (PDF - 87KB) 
  Uniform terms used to designate dosage forms and routes of administration; abbreviations used to designate strengths.