FDA Orange Book Monthly Additions and Deletions to Prescription and OTC Drug Product Lists
Summary
The FDA Orange Book publishes monthly index files documenting new additions and deletions to its list of approved prescription and OTC drug products, covering January 2021 through March 2026. Products are flagged with symbols indicating additions (>ADD>), deletions (>DLT>), or discontinued marketing status (@). The index is a reference companion to the cumulative Orange Book and its supplements.
“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.”
About this source
GovPing monitors FDA Orange Book - Approved Drug Products for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 1 changes logged to date.
What changed
The FDA Orange Book now includes monthly index files tracking new additions and deletions to the approved prescription and OTC drug product lists for January 2021 through March 2026. Products are identified using standardized symbols: >ADD> or >A> for additions, >DLT> or >D> for deletions, and @ for discontinued or non-marketed products. This index is informational and must be used alongside the current Cumulative Supplement and main Orange Book.
Affected parties—primarily pharmaceutical companies, healthcare providers, and regulatory affairs professionals—should consult these monthly indexes when verifying the current approval status of specific drug products. The index does not create new compliance obligations but serves as a reference tool for tracking FDA's ongoing changes to the approved drug product landscape.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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. This information must be used in conjunction with the most current Cumulative Supplement and Orange Book. Additions and deletions are identified in this document by the symbols >ADD> and >DLT>, respectively. Products that have never been marketed, have been discontinued from marketing or that have had their approvals withdrawn for other than safety or efficacy reasons, will be flagged in this Cumulative Supplement with the "@" symbol to designate their non-marketed status. All products having a "@" symbol in the 12th Cumulative Supplement of the current Edition List will then be added to the "Discontinued Drug Product List" of the following Edition.
- >ADD> or >A> indicates Addition
- >DLT> or >D> indicates Deletion
- @ indicates drugs that have been discontinued from marketing or that have had their approvals withdrawn for other than safety or efficacy reasons
2026 Additions and Deletions to Drug Product List
- January 2026: Additions and Deletions to the Drug Product List
- February 2026: Additions and Deletions to the Drug Product List
- March 2026: Additions and Deletions to the Drug Product List
2025 Additions and Deletions to Drug Product List
- January 2025: Additions and Deletions to the Drug Product List
- February 2025: Additions and Deletions to the Drug Product List
- March 2025: Additions and Deletions to the Drug Product List
- April 2025: Additions and Deletions to the Drug Product List
- May 2025: Additions and Deletions to the Drug Product List
- June 2025: Additions and Deletions to the Drug Product List
- July 2025: Additions and Deletions to the Drug Product List
- August 2025: Additions and Deletions to the Drug Product List
- September 2025: Additions and Deletions to the Drug Product List
- October 2025: Additions and Deletions to the Drug Product List
- November 2025: Additions and Deletions to the Drug Product List
- December 2025: Additions and Deletions to the Drug Product List
2024 Additions and Deletions to Drug Product List
- January 2024: Additions and Deletions to the Drug Product List
- February 2024: Additions and Deletions to the Drug Product List
- March 2024: Additions and Deletions to the Drug Product List
- April 2024: Additions and Deletions to the Drug Product List
- May 2024: Additions and Deletions to the Drug Product List
- June 2024: Additions and Deletions to the Drug Product List
- July 2024: Additions and Deletions to the Drug Product List
- August 2024: Additions and Deletions to the Drug Product List
- September 2024: Additions and Deletions to the Drug Product List
- October 2024: Additions and Deletions to the Drug Product List
- November 2024: Additions and Deletions to the Drug Product List
- December 2024: Additions and Deletions to the Drug Product List
2023 Additions and Deletions to Drug Product List
- January 2023: Additions and Deletions to the Drug Product List
- February 2023: Additions and Deletions to the Drug Product List
- March 2023: Additions and Deletions to the Drug Product List
- April 2023: Additions and Deletions to the Drug Product List
- May 2023: Additions and Deletions to the Drug Product List
- June 2023: Additions and Deletions to the Drug Product List
- July 2023: Additions and Deletions to the Drug Product List
- August 2023: Additions and Deletions to the Drug Product List
- September 2023: Additions and Deletions to the Drug Product List
- October 2023: Additions and Deletions to the Drug Product List
- November 2023: Additions and Deletions to the Drug Product List
- December 2023: Additions and Deletions to the Drug Product List
2022 Additions and Deletions to Drug Product List
- January 2022: Additions and Deletions to the Drug Product List
- February 2022: Additions and Deletions to the Drug Product List
- March 2022: Additions and Deletions to the Drug Product List
- April 2022: Additions and Deletions to the Drug Product List
- May 2022: Additions and Deletions to the Drug Product List
- June 2022: Additions and Deletions to the Drug Product List
- July 2022: Additions and Deletions to the Drug Product List
- August 2022: Additions and Deletions to the Drug Product List
- September 2022: Additions and Deletions to the Drug Product List
- October 2022: Additions and Deletions to the Drug Product List
- November 2022: Additions and Deletions to the Drug Product List
- December 2022: Additions and Deletions to the Drug Product List
2021 Additions and Deletions to Drug Product List
- January 2021: Additions and Deletions to the Drug Product List
- February 2021: Additions and Deletions to the Drug Product List
- March 2021: Additions and Deletions to the Drug Product List
- April 2021: Additions and Deletions to the Drug Product List
- May 2021: Additions and Deletions to the Drug Product List
- June 2021: Additions and Deletions to the Drug Product List
- July 2021: Additions and Deletions to the Drug Product List
- August 2021: Additions and Deletions to the Drug Product List
- September 2021: Additions and Deletions to the Drug Product List
- October 2021: Additions and Deletions to the Drug Product List
- November 2021: Additions and Deletions to the Drug Product List
- December 2021: Additions and Deletions to the Drug Product List
2020 Additions and Deletions to Drug Product List
- January 2020: Additions and Deletions to the Drug Product List
- February 2020: Additions and Deletions to the Drug Product List
- March 2020: Additions and Deletions to the Drug Product List
- April 2020: Additions and Deletions to the Drug Product List
- May 2020: Additions and Deletions to the Drug Product List
- June 2020: Additions and Deletions to the Drug Product List
- July 2020: Additions and Deletions to the Drug Product List
- August 2020: Additions and Deletions to the Drug Product List
- September 2020: Additions and Deletions to the Drug Product List
- October 2020: Additions and Deletions to the Drug Product List
- November 2020: Additions and Deletions to the Drug Product List
- December 2020: Additions and Deletions to the Drug Product List
2019 Additions and Deletions to Drug Product List
- January 2019: Additions and Deletions to the Drug Product List
- February 2019: Additions and Deletions to the Drug Product List
- March 2019: Additions and Deletions to the Drug Product List
- April 2019: Additions and Deletions to the Drug Product List
- May 2019: Additions and Deletions to the Drug Product List
- June 2019: Additions and Deletions to the Drug Product List
- July 2019: Additions and Deletions to the Drug Product List
- August 2019: Additions and Deletions to the Drug Product List
- September 2019: Additions and Deletions to the Drug Product List
- October 2019: Additions and Deletions to the Drug Product List
- November 2019: Additions and Deletions to the Drug Product List
- December 2019: Additions and Deletions to the Drug Product List
2018 Additions and Deletions to Drug Product List
- January 2018: Additions and Deletions to the Drug Product List
- February 2018: Additions and Deletions to the Drug Product List
- March 2018: Additions and Deletions to the Drug Product List
- April 2018: Additions and Deletions to the Drug Product List
- May 2018: Additions and Deletions to the Drug Product List
- June 2018: Additions and Deletions to the Drug Product List
- July 2018: Additions and Deletions to the Drug Product List
- August 2018: Additions and Deletions to the Drug Product List
- September 2018: Additions and Deletions to the Drug Product List
- October 2018: Additions and Deletions to the Drug Product List
- November 2018: Additions and Deletions to the Drug Product List
- December 2018: Additions and Deletions to the Drug Product List
2017 Additions and Deletions to Drug Product List
- January 2017: Additions and Deletions to the Drug Product List
- February 2017: Additions and Deletions to the Drug Product List
- March 2017: Additions and Deletions to the Drug Product List
- April 2017: Additions and Deletions to the Drug Product List
- May 2017: Additions and Deletions to the Drug Product List
- June 2017: Additions and Deletions to the Drug Product List
- July 2017: Additions and Deletions to the Drug Product List
- August 2017: Additions and Deletions to the Drug Product List
- September 2017: Additions and Deletions to the Drug Product List
- October 2017: Additions and Deletions to the Drug Product List
- November 2017: Additions and Deletions to the Drug Product List
- December 2017: Additions and Deletions to the Drug Product List
2016 Additions and Deletions to Drug Product List
- January 2016: Additions and Deletions to the Drug Product List
- February 2016: Additions and Deletions to the Drug Product List
- March 2016: Additions and Deletions to the Drug Product List
- April 2016: Additions and Deletions to the Drug Product List
- May 2016: Additions and Deletions to the Drug Product List
- June 2016: Additions and Deletions to the Drug Product List
- July 2016: Additions and Deletions to the Drug Product List
- August 2016: Additions and Deletions to the Drug Product List
- September 2016: Additions and Deletions to the Drug Product List
- October 2016: Additions and Deletions to the Drug Product List
- November 2016: Additions and Deletions to the Drug Product List
- December 2016: Additions and Deletions to the Drug Product List
2015 Additions and Deletions to Drug Product List
- January 2015: Additions and Deletions to the Drug Product List
- February 2015: Additions and Deletions to the Drug Product List
- March 2015: Additions and Deletions to the Drug Product List
- June 2015: Additions and Deletions to the Drug Product List
- July 2015: Additions and Deletions to the Drug Product List
- August 2015: Additions and Deletions to the Drug Product List
- September 2015: Additions and Deletions to the Drug Product List
- November 2015: Additions and Deletions to the Drug Product List
- December 2015: Additions and Deletions to the Drug Product List
2014-2007 Additions and Deletions to Drug Product Lists can be found in the FDA Archive
- ## Content current as of:
04/10/2026
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