Approved Drug Products with Therapeutic Equivalence Evaluations (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.
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 2017 (PDF – 2MB)
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 – 168KB)
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 – 408KB)
Product Name Index listed by Applicant (prescription and OTC product lists). Cross-references applicants to drug products. Updated quarterly.
- Appendix C: Uniform Terms (PDF – 24KB)
Uniform terms used to designate dosage forms and routes of administration; abbreviations used to designate strengths.
Continue at: https://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm#printable
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