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)

The U.S. Food and Drug Administration (FDA) today introduced an important data update to Approved Drug Products with Therapeutic Equivalence Evaluations – known as the “Orange Book.” Search results and drug listings now clarify which listed drugs are reference listed drugs (RLDs) and which are reference standards. Listings also indicate which products in the Discontinued Section may be referred to as an RLD. The FDA made these modifications to reflect recent clarifications published in the draft guidance for industry “Referencing Approved Drug Products in ANDA Submissions.” The print edition of the Orange Book also reflects these updates; the Orange Book mobile app will be updated in the near future.

These updates will help applicants submitting an abbreviated new drug application (ANDA) to seek approval of a generic drug to identify:

• an RLD, i.e., a previously approved drug product for which an applicant may seek approval of a generic drug;
• a reference standard, i.e., the previously approved drug selected by FDA that an applicant must use in the conduct of in vivo bioequivalence studies required for approval of an ANDA; and
• the basis of submission for the ANDA.

Further information is available in the pre-recorded webinar, “Referencing Approved Drug Products in ANDA Submissions.”

Please note that the 37^th edition Orange Book Preface is now available on the web or as a downloadable PDF (8.4MB).

The Orange Book, which identifies drug products approved by the FDA, first appeared as a published list in October 1980. Since 1984, the Orange Book has also included information about patents and exclusivity for listed products. In 1997, the FDA made the Orange Book database available for searching on the Web. Today, “Orange Book” is one of the most searched-for terms on FDA.gov.

Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

The Orange Book

PLEASE NOTE: On January 25, 2017, The Orange Book reference standard and RLD data were updated - details here.

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

FDA’s Orange Book Web Search Has a New Look and New Features!

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 Searching the Orange Book is now faster and easier with our new mobile app!

Download Orange Book Express

  

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 - 1.8MB) 
  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 - 185KB) 
  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 - 958KB) 
  Product Name Index listed by Applicant (prescription and OTC product lists). Cross-references applicants to drug products. Updated quarterly.
• Appendix C: Uniform Terms (PDF - 108KB) 
  Uniform terms used to designate dosage forms and routes of administration; abbreviations used to designate strengths.

Additional Resources

• Additions/Deletions for Prescription and OTC Drug Product Lists 
  Additions and deletions to the Prescription and OTC Drug Product Lists for a specific month
• Orange Book Data Files (compressed) (ZIP - 639KB) 
  Download the Orange Book Data files (updated monthly). For more information, including the descriptions of data fields in the Orange Book Search, see Orange Book Data Files.
• Orange Book FR Safety or Effectiveness Determinations List 
  List of approved drug products that have had Federal Register Citizen Petition Notices stating that the FDA has determined that the approved drug product was not discontinued for safety or effectiveness reasons
• Frequently Asked Questions on The Orange Book
• Frequently Asked Questions on Patents and Exclusivity
• Orange Book Preface

Contact Us

The Orange Book downloadable data files are updated monthly. We make every effort to prevent errors and discrepancies in the Approved Drug Products data files; however, if you wish to report an error or discrepancy in drug data, please send a brief description of the problem to orangebook@fda.hhs.gov.

General questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information druginfo@fda.hhs.gov.

Requests for more specific information should be submitted in writing or directed to the FDA's Freedom of Information (FOIA) Staff.