Fda orange book use codes

How do i use the electronic orange book to find approved generic drugs. Codes beginning with a signify the product is deemed therapeutically equivalent to the reference product for the category. Fdas proposed rules to address inaccurate orange book. May repeat for multiple applications, multiple products and multiple patents. Finally, the orange book lists patents that are purported to protect each drug. Codes beginning with b indicate bioequivalence has not been confirmed. Food and drug administration fda has approved as both safe and effective.

Orange book codes the orange book codes supply the fda s therapeutic equivalence rating for applicable multisource categories. Cfr code of federal regulations title 21 food and drug. Patent use code code to designate a use patent that covers the approved indication or use of a drug product. The electronic availability of the orange book brings this valuable tool to the web for healthcare. Approved drug products with therapeutic equivalence. The orange book has long been a reliable resource for information about fda approved drugs. The nda holder must confirm the correctness of its description of the approved method of use claimed by the patent that has been included as the use code in the orange book, or withdraw or amend the patent information in accordance with paragraph f2 of this section, provide a narrative description no more than 250 words of the nda holders interpretation of the scope of the patent that explains why the existing or amended use code describes only the specific approved method of use.