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                Drug Approvals and Databases

Drug Approvals and Databases

                        


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          Drug Approvals and Databases
          Approved Drug Products with Therapeutic Equivalence Evaluations | Orange BookDrug Approvals and Databases Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book
  
  	
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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.

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Orange Book Publications, Supplements, and Appendices
	Orange Book Patent & Exclusivity Information
	Additional Orange Book Resources
	Related Guidance and References
	Contact UsOrange Book Publications, Supplements, and Appendices

Orange Book Annual Edition (PDF - 10 MB)
	Orange Book Preface
	Orange Book Current Cumulative Supplement (PDF - 2.4 MB)
	Appendix A: Product Name Index (PDF - 177 KB)
	Appendix B: Product Name Sorted by Applicant (PDF - 482 KB)
	Appendix C: Uniform Terms (PDF - 125 KB)Orange Book Patent & Exclusivity Information

Orange Book Patent Listing Dispute List (PDF - 829 KB)
	Section 314.53(f)(1) outlines a process through which a person can dispute the accuracy or relevance of patent information published in the Orange Book, as well as the process for the relevant new drug application (NDA) holder to respond to such disputes. For all patent listing disputes, FDA promptly posts information on (1) whether a patent listing dispute has been submitted to FDA and (2) whether the NDA holder has timely responded to the patent listing dispute. The Patent Listing Dispute List contains relevant drug product information and the disputed patent. The list is cumulative in nature and is organized by drug product established name and patent number(s).
	List of Patent Use Codes and Definitions
	List of Exclusivity Codes and Definitions – includes lists of codes with numbers and codes without numbers.
	Frequently Asked Questions on Patents and ExclusivityAdditional Orange Book Resources

Frequently Asked Questions on The Orange Book
	Orange Book Data Files (compressed .zip file)
	For additional information, such as descriptions of data fields in the Orange Book Search, please see Orange Book Data Files.
	Additions/Deletions for Prescription and OTC Drug Product Lists
	Reference Listed Drugs by ANDA Reference Standard List (PDF - 115 KB)
	Pre-Hatch-Waxman Abbreviated New Drug Applications (PANDA) in the Orange Book (PDF - 1.76MB)Related Guidance and References

Guidance for Industry:
	Orange Book Questions and Answers (July 2022)
		Evaluation of Therapeutic Equivalence (July 2022)
		Referencing Approved Drug Products in ANDA Submissions (October 2020)
		Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act (August 2020)
	Reference standard data updates to the Orange Book (January 2017)
	Biologics Price Competition and Innovation Act (BPCIA) of 2009:
	BPCIA Orange Book Transition Edition (PDF - 9.6 MB)
		“Deemed to be a License” Provision of the BPCI Act (April 2020)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**.

                                                                                  Content current as of:
      01/12/2024Drug Approvals and Databases

          
                        


                        Resources for Information | Approved Drugs
 
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