public-service · FDA Orange Book monthly change list
Can You Still Get an Old FDA Orange Book Monthly Change List?
Yes—FDA's monthly Orange Book change-list archive still serves entries from January 2015 through July 2026.
In this article
Updated: Sources: 2
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What matters now
- FDA's monthly Orange Book change-list archive page is still live and still opens with the same scope-defining sentence.
- The page currently lists individual monthly entries from January 2015 through July 2026.
- 2007-2014 entries are not listed directly; the page points readers to the separate FDA Archive for that range.
- Since the 25th edition, the Annual Edition and monthly Cumulative Supplements have been provided as downloadable PDFs.
FDA’s archive page for Orange Book monthly change lists defines each document as a list of additions and deletions for a specific month. The page lists individual monthly entries from January 2015 through July 2026 and directs readers to the FDA Archive for the 2007–2014 range.
This original record-reading guide is a general reading aid, not cited evidence. It does not depict a source record; the article text and source links provide the facts.
Key points
- The archive page defines each monthly document as a change list, not a cumulative list of approved drugs (FDA archive page).
- The page lists individual monthly entries from January 2015 through July 2026 (FDA archive page).
- For 2007–2014, the page directs readers to the FDA Archive (FDA archive page).
- The Cumulative Supplement says that, starting with the 25th edition, both the Annual Edition and monthly Cumulative Supplements have been provided as downloadable PDFs (FDA Cumulative Supplement).
Monthly change list
The archive page opens by defining exactly what each monthly document covers, and what it does not cover:
“This document is not a cumulative list of approved Prescription and OTC Drug Products but a list of the new additions and new deletions to the Prescription and OTC Drug Product Lists for a specific month.” — https://www.fda.gov/drugs/informationondrugs/ucm086229.htm
That sentence defines the document as a snapshot of additions and deletions for one month rather than a running total of approved products.
Current and routed listings
The archive page lists individual monthly change-list entries running from January 2015 through July 2026. For the earlier span, the page directs readers elsewhere:
“2014-2007 Additions and Deletions to Drug Product Lists can be found in the FDA Archive” — https://www.fda.gov/drugs/informationondrugs/ucm086229.htm
For the page’s listed 2015–2026 range, the individual monthly entries appear on that page. The page directs readers seeking the 2007–2014 range to the FDA Archive.
Cumulative Supplement format
Separately, the Orange Book’s own Cumulative Supplement document describes how these monthly and annual documents have been delivered since a specific edition:
“Commencing with the 25th edition, the Annual Edition and monthly Cumulative Supplements have been provided in downloadable Portable Document Format (PDF) at the EOB home page by clicking on Publications.” — https://www.fda.gov/media/72973/download?attachment
This tells a reader that, from the 25th edition onward, both the yearly Annual Edition and the monthly Cumulative Supplements have been distributed as PDFs accessible through a “Publications” link on the Orange Book’s home page.
What this article does not answer
This article covers only the monthly change-list page and the cited supplement language. It does not address availability outside the ranges the archive page describes or speculate about FDA’s retention choices or future changes.