Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Drug Approvals and Databases

Drug Approvals and Databases

                        


                        Resources for Information | Approved Drugs Home
          Drugs
          Development & Approval Process | Drugs
          Drug Approvals and Databases
          Additions/Deletions for Prescription and OTC Drug Product ListsDrug Approvals and Databases Additions/Deletions for Prescription and OTC Drug Product Lists
  
  	
    Share
    Post
    Linkedin

    Email
    PrintOrange Book Home Page

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**

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 List2021 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 List2020 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 List2019 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 List2018 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 List2017 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 List2016 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 List2015 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 List2014-2007 Additions and Deletions to Drug Product Lists can be found in the FDA Archive

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

          
                        


                        Resources for Information | Approved Drugs
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop