> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Posts Q & A Guide on Orange Book
- URL: https://www.fdaweb.com/fda-posts-q-a-guide-on-orange-book/
- Published: 2022-07-22T12:00:00.000Z
- Updated: 2026-09-14T17:52:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152343

FDA has issued a final guidance entitled “[*Orange Book* Questions and Answers](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDIsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMjA3MjIuNjExNTM4NjEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L3JlZ3VsYXRvcnktaW5mb3JtYXRpb24vc2VhcmNoLWZkYS1ndWlkYW5jZS1kb2N1bWVudHMvb3JhbmdlLWJvb2stcXVlc3Rpb25zLWFuZC1hbnN3ZXJzLWd1aWRhbmNlLWluZHVzdHJ5P3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSJ9.0DuX%5FHypHUS4Tzq9Ss4-KbV0Fezl71Dbhun0nXA4j0A/s/1255931999/br/141452268465-l?ref=fdaweb.com)” that answers commonly asked questions it has received from interested parties. It covers topics such as the content and format of the *Orange Book*, petitioned ANDAs, drug products moving between the Active and Discontinued sections, and drug product and patent listings. The agency notes that the *Orange Book* web site ([https://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm](https://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm?ref=fdaweb.com)) also has a number of additional resources that can assist stakeholders with using it and related questions.