Drug Approvals and Databases > Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
About the Orange Book 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.) The Approved Drug Products list first appeared as a print publication in 1980. With the 25th edition (2005), Portable Document Format (PDF) versions of the Annual Edition and the Cumulative Supplement became available. The Orange Book Search was added to the FDA website October 31, 1997. |
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- Orange Book Search
You can search by active ingredient, proprietary name, applicant, or application number.
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Orange Book Publications
- Orange Book Annual Edition (PDF - 10.2MB)
32nd 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 - 1.3MB)
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. - Additions/Deletions for Prescription and OTC Drug Product Lists
Changes to the annual edition are listed separately by month.
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Downloadable Files
- About the Orange Book Data Files
Descriptions of data fields in the Web version of the Orange Book. - Orange Book Data Files (compressed) (ZIP - 533KB)
Download the file. Updated monthly. - Appendix A: Product Name Index (PDF - 142KB)
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 - 525KB)
Product Name Index Listed by Applicant (prescription and OTC product lists). Cross-references applicants to drug products. Updated quarterly. - Appendix C: Uniform Terms (PDF - 46KB)
Uniform terms used to designate dosage forms and routes of administration; abbreviations used to designate strengths.
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Help and Background Information
- Frequently Asked Questions on The Orange Book
- Frequently Asked Questions on Patents and Exclusivity
- Orange Book Preface
- Orange Book updates
- Additions/Deletions for Prescription and OTC Drug Product Lists
- Appendix A: Product Name Index (PDF - 142KB)
- Appendix B: Product Name Sorted by Applicant (PDF - 525KB)
- Appendix C: Uniform Terms (PDF - 46KB)
- Orange Book Current Cumulative Supplement (PDF - 1.3MB)
- Orange Book Data Files (compressed) (ZIP - 533KB)
- Orange Book FR Safety or Effectiveness Determinations List (PDF) (PDF - 193KB)
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